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The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent.
On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration.
The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec.
View full story: https://www.biocentury.com/article/657192
#biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN
00:01 Sponsor Message: Evotec
03:31 Pfizer MFN Deal
16:05 PDUFA Reauthorization
20:31 Investigator-Initiated Trials
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.
The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/657131
#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN
00:01 - Sponsor Message: IQVIA Biotech
02:26 - Genmab's Merus Buy
09:43 - CEO Switch at GSK
17:22 - Trump Tariff Threat
21:17 - MFN Drug Pricing
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/657086
#Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking
00:01 - Sponsor Message: IQVIA Biotech
01:22 - AI in Biotech
05:01 - Machine Learning
06:21 - Generative AI and Language Models
08:37 - Agentic AI
12:43 - AI in Target Discovery
23:44 - AI in Clinical Trial Design
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference.
Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s major science themes, including what’s next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design.
View full story: https://www.biocentury.com/article/657082
#UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking
00:00 - Introduction
00:35 - Key Takeaways
02:14 - The State of the U.K. Biotech Ecosystem
09:01 - Scientific Highlights & Panel Takeaways
22:44 - Closing Remarks and Future Events
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore.Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/657065
#ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy
00:01 - Sponsor Message: IQVIA Biotech
03:46 - Pfizer’s Obesity M&A
14:54 - U.K. in Focus
28:20 - U.S. Drug Pricing, China Policy
40:07 - Narcolepsy Pipeline
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656997
#biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment
00:01 - Sponsor Message: IQVIA Biotech
01:25 - U.K. Biopharma
04:40 - Grand Rounds Cambridge
09:45 - SAFE Research Act
18:01 - Spotlight on Insmed
26:32 - Sen. Cassidy's Vaccine Callout
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87.
The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656942
#biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent
00:01 - Sponsor Message: IQVIA Biotech
03:19 - Remembering David Baltimore
06:26 - Atlas's New Opportunity Fund
09:22 - The Growing MASH Pipeline
16:03 - Sanofi's Atopic Dermatitis Data
18:57 - Exploring Chronic Urticaria Treatments
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease.
The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July.
View full story: https://www.biocentury.com/article/656897
#Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing
00:00 - Introduction
01:26 - Maraganore, Meanwell Newco
09:17 - BioCentury's Back to School
14:51 - Vaccine Disruption at FDA
26:01 - Medicare Drug Negotiations
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.
The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.
View full story: https://www.biocentury.com/article/656849
#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO
00:00 - Introduction
02:48 – LB Pharma Tests IPO Market
07:01 – Hong Kong IPO Momentum
09:53 – China Summit Preview
13:40 – FDA Reversal on Stealth Bio
18:15 – Bayh-Dole Clash & Innovation Threats
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends.
The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.
BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.
View full Story: https://www.biocentury.com/article/656802
#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration
00:00 - Introduction
01:38 - Pharma Deals
10:41 - Precigen
14:40 - Denali's BBB Tech
25:20 - Grand Rounds Europe
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.
These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.
BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here.
View full story: https://www.biocentury.com/article/656773
#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance
00:00 - Introduction
02:09 – Key Trends
06:03 – View from McKinsey
13:36 – Evolution of Deal Landscape
20:24 – Learning from China
24:00 – China-China M&A & NewCos
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.
They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.
Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs.
View full story: https://www.biocentury.com/article/656727
#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals
00:00 - Introduction
00:49 - Prasad
07:09 - Back to School
12:29 - Lilly Obesity
21:58 - Acadia's Comeback
28:50 - Biosecure Act
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.
The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.
View full story: https://www.biocentury.com/article/656649
#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer
01:05 - Prasad's Ouster
14:59 - Novo's New CEO
21:14 - Bayer's Growth Strategy
26:05 - Masked Biologics
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.
Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.
View full story: https://www.biocentury.com/article/656614
#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy
00:01 – Sponsor Message: IQVIA Biotech
02:37 – Biotech Markets
06:41 – Clinical Highlights
10:26 – Insights from Meg Hooton
23:10 – Advanced Therapies
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.
On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.
BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656592
#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy
00:01 - Sponsor Message: IQVIA Biotech
02:48 - Asia Deals Landscape
17:32 - Steve Bates & U.K. Biotech
25:46 - FDA's New Voucher Pilot
31:01 - New VC Funds
35:28 - Sarepta
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.
BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656537
#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys
00:01 - Sponsor Message: IQVIA Biotech
02:03 - Gene Therapy
17:59 - Leading CDER
27:00 - Venture Report
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office. This episode of BioCentury This Week was sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656482
#biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputing
00:01 - Sponsor Message: IQVIA Biotech
04:43 - Q25 Financial Markets Preview
22:20 - Quantum Computing Impact on Biopharma
30:07 - Makary's First 100 Days
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference.
On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital; Sally Mardikian, business development director, Astrazeneca; and Kristin-Anne Rutter, executive director of Cambridge University Health Partners.
The BioCentury team and its Cambridge counterparts discuss the conference’s themes and how they relate to the region’s strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners.
View full story: https://www.biocentury.com/article/656373
#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEurope
00:00 - Introduction
01:53 - Grand Rounds Cambridge Themes
10:14 - Why Cambridge?
23:43 - Tough Love
28:02 - Join us at GlastonGeek
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics.
Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech.
View full story: https://www.biocentury.com/article/656371
#biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T
00:01 - Sponsor Message: ICON Biotech
02:30 - FDA Cancer Regulations
07:48 - Project Optimus
25:12 - CAR T REMS Removal
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile.
The team also explores the biotech sector’s ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back.
The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/656376
#biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T
00:01 - Sponsor Message: IQVIA Biotech
01:19 - Treg Inflection Point
10:57 - Biotech's Next Big Story
22:36 - Tax Bill Consequences
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape.
The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/656341
#biotech #biopharma #pharma #lifescience #RandD #drugapproval
00:01 - Sponsor Message: ICON Biotech
02:26 - BioCentury Grand Rounds Europe
05:02 - FDA's Future
15:03 - Psychedelics
22:53 - Esobiotech's Fast Exit
31:37 - Molecular Glues and CDK2
34:43 - Abbvie's Capstan Buy
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ’s largest biopharma IPO — by Caris — in two years, the latest obesity readouts, FDA Commissioner Marty Makary’s priority pathway and Usdin’s Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/656266
#biotech #biopharma #pharma #lifescience #finance #CV #FDA
00:01 - Sponsor Message: ICON Biotech
02:14 - Syncona Restructures Fund
10:08 - Lilly's $1B Verve Takeout
21:45 - FDA's 2-Track Future
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The tragic death of a second non-ambulatory DMD patient treated with Sarepta's Elevidys gene therapy marks a turning point for the field and should drive all stakeholders to come together to figure out how to safely treat patients with this new modality. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the opportunity FDA, companies and patient advocates have to share data and identify a safe path forward for the gene therapy field, both in DMD and beyond.
The analysts also review promising early data for amylin agonists to treat obesity from Metsera and Eli Lilly, and discuss the vision for FDA’s future laid out by Commissioner Marty Makary and CBER director Vinay Prasad. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/656214
#biotech #biopharma #pharma #lifescience #obesity #FDA #DMD
00:01 - Sponsor Message: ICON Biotech
01:19 - Gene Therapy Safety
11:55 - Amylin in Obesity
18:17 - FDA's Future
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
With federal funding at risk and VCs increasingly focused on de-risked assets, academia is facing unprecedented headwinds despite rapid advancements in innovation.
One potential bright spot: Pharma, which is turning to academia to access first-in-class innovation. But many in pharma complain it is difficult to work with academia.
On a special Grand Rounds edition of the BioCentury This Week podcast, BioCentury analysts and special guests discuss a new way of thinking and a new era of collaboration between academia and industry.
View full story: https://www.biocentury.com/article/656177
#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRounds
00:00 - Introduction
02:38 - Key Findings
07:42 - Collaboration and Opportunities
25:52 - BioCentury Grand Rounds Europe
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Translational trends at this year’s ASCO meeting featured new and selective ways to target cell surface receptors on solid tumors. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the findings from Executive Director of Biopharma Intelligence Lauren Martz’s deep dive into first-in-human studies at the American Society of Clinical Oncology meeting, including how immunocytokines, solid tumor CAR Ts and Chinese innovation are thriving in early trials.
The analysts also examine the signs of strain and resilience in biotech’s crossover investors, as well as FDA’s plans for revamping rare disease regulation. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/656139
#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment
00:01 - Sponsor Message: ICON Biotech
02:11 - ASCO’s First-in-Human Trials
12:46 - Crossover Investor Health Check
22:54 - FDA's Rare Disease Plans
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma’s already strong presence in immunology.
The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer’s hottest target, PD-(L)1 x VEGF, and underwhelming data from the leading asset against the target, PD-1 x VEGF bispecific ivonescimab, from Summit and Akeso Inc. Those data coincided with the kick-off of the American Society of Clinical Oncology (ASCO) meeting in Chicago, where almost a dozen companies were presenting readouts for another hot target, CLDN18.2. Evopoint is among the companies; its program recently attracted Astellas as a partner.
Meanwhile, the biopharma industry is racing to counter the White House’s most favored nation drug pricing strategy. BioCentury’s Washington analyst, Steve Usdin, explains the urgency and details some of industry’s options.
View full story: https://www.biocentury.com/article/656097
#biotech #biopharma #pharma #lifescience #deals
00:00 - Introduction
04:39 - Sanofi Buys Blueprint
09:22 - BMS-BioNTech
20:01 - Hot Targets
23:40 - Drug Pricing
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Dutch biotech Merus’ EGFR x LGR5 bispecific antibody has caught investors’ attention in the run-up to ASCO as a new approach to block EGFR signaling. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Phase II data from Merus for petosemtamab as they preview the American Society of Clinical Oncology’s upcoming annual meeting. The analysts also assess a setback in a gene therapy trial for Rocket Pharmaceuticals, renewed interest in cancer target EpCAM, and a flurry of biopharma activity on the Hong Kong stock exchange. Finally, the team previews BioCentury’s second annual Grand Rounds R&D meeting, which takes place next week in Chicago. This episode was sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/656038
#biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment
00:01 - Sponsor Message: Jeito Capital
24:52 - HK IPOs
07:12 - ASCO
16:37 - EpCAM
20:16 - Rocket
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Political and market turmoil has raised questions whether the U.S. can retain its biopharma leadership position, and in turn presents Europe with an opportunity to attract talent back to the continent with an offer of a more stable biomedical funding and regulatory environment. Jeito Capital’s Ksenija Pavletic and Cambridge Innovation Capital’s Anne Horgan join BioCentury’s analyst to wrap up the 25th annual Bio€quity Europe conference in Bruges, Belgium, by discussing their key takeaways from the two-day event. This episode was sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/655998
#biotech #biopharma #pharma #lifescience #networking
00:01 - Sponsor Message: Jeito Capital
02:10 - Key Takeaways
09:13 - Challenges and Opportunities for Europe
19:23 - Capital Efficiency and Success Stories
28:27 - Leadership, Teams & Talent
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The turbulence that has come with the Trump administration’s policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury’s editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China.
The editors also discuss two biotech deals driven by former leaders of BD at Roche, Biomarin's James Sabry and Sophie Kornowski at Boston Pharmaceuticals. Under the leadership of Sabry and CEO Alexander Hardy, Biomarin delivered its first takeout in a decade by acquiring Inozyme as it positions itself to take advantage of a regulatory and policy environment that they believe is favorable to their rare disease strategy. CEO Kornowski, meanwhile, executed on a plan to focus her company on a single liver disease asset that GSK acquired for $1.2 billion up front. Finally, BioCentury’s editors discuss the management shake-up at obesity company Novo Nordisk, where Lars Fruergaard Jørgensen, the leader who spearheaded Novo Nordisk’s transformation into a dominant player in obesity, is stepping down.
Chan Zuckerberg Chicago Biohub is hosting an exclusive, invite-only reception on June 3 — the eve of BioCentury's Grand Rounds conference — gathering top voices in biotech innovation and investment to exchange bold ideas, spark new collaborations and channel the energy of Chicago’s thriving innovation ecosystem. If you’re interested in attending, please register here. This episode was sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/655964
#biotech #biopharma #pharma #lifescience #politics #policy #law
00:01 - Sponsor Message: Jeito Capital
05:05 - European Biotech's Moment?
19:00 - Boston Pharma, Biomarin Deals
29:41 - Novo Nordisk CEO
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Biopharmas developing therapies for obesity are looking to a future where the quality of weight loss matters as much as the quantity — what targets and programs could help realize that vision? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the signaling pathways that may exclusively target fat mass while preserving, or even increasing, lean mass — and which companies are playing in the space.
The editors also assess what Vinay Prasad’s past comments say about how he might lead FDA’s Center for Biologics Evaluation and Research (CBER) — and examine how investors are evaluating the possibility that he might move the bar for regulatory approvals. The team then introduces the first in a new BioCentury series, with a look at a Literature Dive into ovarian cancer “atlases” — large-scale molecular profiling studies that point to predictive signatures and patient stratification strategies. This episode was sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/655898
#biotech #biopharma #pharma #obesity #FDA #CBER #LifeScience #OvarianCancer
00:01 - Sponsor Message: Jeito Capital
03:22 - Obesity: Quality over Quantity
15:47 - Prasad at FDA
27:58 - Ovarian Cancer Atlases
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
This year’s Bio€quity Europe conference — the 25th edition of the event — will focus on what’s next for Europe amid biotech’s current complex moment, Editor in Chief Simone Fishburn said on a special edition of the BioCentury This Week podcast previewing the meeting, which kicks off May 12 in Bruges, Belgium. McKinsey & Co.’s Alexandra Zemp and Henk Joos, an investment specialist at Medvia, which fosters health innovation in Flanders, joined BioCentury to discuss the state of Belgium’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. Claire Macht, portfolio director, Europe, of BioCentury’s conference partner EBD Group, also joined the podcast to detail what to expect in terms of one-on-one partnering meetings at the event.
Bio€quity Europe 2025 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.
View full story: https://www.biocentury.com/article/655883
#biotech #biopharma #pharma #networking #LifeScience
00:00 - Introduction
01:25 - What's Next for Europe?
06:58 - Belgium's Biotech Ecosystem
10:29 - McKinsey on European Biotech
15:27 - Partnering, Panels of Note
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Among the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year’s American Association for Cancer Research (AACR) annual meeting.
They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation with David Baker, the Nobel-prizewinning pioneer in protein design, and Steve Usdin reports that pharmaceutical industry executives are in a state of alarm over President Trump’s push to include a “most favored nation” policy for Medicaid drug purchases in budget reconciliation legislation. Usdin also discusses why industry executives are confident of a fix for the Inflation Reduction Act’s “pill penalty” and FDA Commissioner Marty Makary’s decision to reject proposals to reorganize the agency. This episode was sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/655851
#biotech #biopharma #pharma #LifeScience #RandD #DrugDevelopment #AACR #SMARCA2
00:01 - Sponsor Message: Jeito Capital
03:01 - AACR Spotlight
11:21 - David Baker Protein Design
19:12 - Trump's Drug Pricing Plan
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Belief in tau — both as a target and surrogate endpoint — for Alzheimer’s is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week’s episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration’s regulation of vaccines, a topic that’s also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commentary published Monday. BioCentury’s editors then discuss delays for drug regulation at FDA, Merck KGaA's $3.9 billion deal to acquire Springworks, and why biotech IPOs could soon have a moment in Hong Kong. This episode of BioCentury This Week podcast is sponsored by RemeGen.
View full story: https://www.biocentury.com/article/655780
#biotech #biopharma #pharma #lifescience #alzheimers #RandD #DrugDevelopment #IPO
00:01 - Sponsor Message: RemeGen Co.
02:06 - Tau Time for Alzheimer's
13:10 - Vaccine Drama at FDA
23:32 - Merck KGaA's SpringWorks Buy
24:52 - Hong Kong Biotech IPOs
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Biopharma companies are vying to dethrone Vyvgart as a leading therapy for myasthenia gravis, with the latest data for therapies treating the rare autoimmune neuromuscular disease coming at this month’s American Academy of Neurology. On a special episode of the BioCentury This Week podcast, BioCentury’s editors discuss the landscape for MG therapies, including anti-BLyS and APRIL therapy telitacicept from Remegen. Joining BioCentury’s editors are Qing Zuraw, chief development officer of podcast sponsor RemeGen, and Amit Sachdev, PI on global trials of the biotech’s therapy. BioCentury’s editors also preview the American Association for Cancer Research annual meeting, where degraders and bispecifics are defining translational trends at this year’s event. This episode of BioCentury This Week podcast was sponsored by RemeGen.
View full story: https://www.biocentury.com/article/655751
#biotech #biopharma #pharma #lifescience #AAN #AACR
00:01 - Sponsor Message: RemeGen Co.
01:02 - Myasthenia Gravis at AAN
08:31 - RemeGen's Telitacicept
18:03 - AACR: Targets and Trends
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The academia-industry interface is more important than ever for sustaining biomedical innovation’s forward momentum, even as the Trump administration injects turbulence into academic funding for universities. On a special edition of the BioCentury This Week podcast, BioCentury’s Simone Fishburn and Karen Tkach Tuzman preview Grand Rounds, BioCentury’s second annual R&D conference, along with special guests.
Spots are filling up for the Grand Rounds U.S. Presenting Company Class of 2025. Find out how to apply here.
View full story: https://www.biocentury.com/article/655696
#biotech #biopharma #pharma #lifescience #academia #chicago #asco
00:00 - Introduction
01:42 - Key Themes and Featured Sessions
07:37 - Chicago's Role in Biotech Innovation
15:06 - McKinsey's Insights
25:18 - Upcoming Events and Networking Opportunities
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advisory committee meetings, as well as last week’s executive order on drug pricing. They also discuss how China’s biotechs may have cracked one of the key bottlenecks for both speeding up and de-risking early drug development — and what this means for U.S. biotech. This episode of BioCentury This Week podcast was sponsored by RemeGen.
View full story: https://www.biocentury.com/article/655690
#biotech #biopharma #pharma #lifescience #FDA #politics #policy #law
00:01 - Sponsor Message: RemeGen Co.
02:00 - Sentiment Survey
20:18 - Makary's FDA Plans
29:51 - China Speed
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn’t falling just yet for biotech’s specialist investors. The editors also highlight recent stories on base editors’ efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.
View full story: https://www.biocentury.com/article/655622
00:01 - Sponsor Message: RemeGen Co.
02:38 - Replacing Animal Models
09:40 - RFK Jr. & FDA
19:36 - NIH
30:02 - BioPharma Market Pulse
33:23 - Innovation Highlights
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war.
The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need to lean on their bear market survival toolkit, as part of BioCentury’s 2Q25 Financial Markets Preview. This episode of BioCentury This Week was sponsored by RemeGen Co.
View full story: https://www.biocentury.com/article/655566
00:01 - Sponsor Message: RemeGen Co.
01:19 - FDA and Tariffs Turmoil
16:54 - AACR Preview
20:44 - Bear Market Toolkit
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary RFK Jr. and the threat of tariffs weigh on a key biotech index. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the factors driving down the XBI, which has now crossed into bear market territory and the latest turmoil at FDA, now that CBER Director Peter Marks has been ousted. Plus, inflammation and immunology companies are finding ways beyond precision medicine to boost responses. BioCentury’s editors assess one approach — bispecific antibodies that block two inflammatory pathways instead of one.
View full story: https://www.biocentury.com/article/655488
00:00 - Introduction
00:51 - XBI's Return to the Bear Market
11:26 - Marks Ouster & Turmoil at FDA
18:07 - Bispecifics for I&I
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
European venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump’s threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA’s staff is navigating the policies of the new administration. Finally, Editor in Chief Simone Fishburn discusses BioCentury's upcoming Grand Rounds meetings.
View full story: https://www.biocentury.com/article/655438
00:00 - Introduction
02:25 - Sofinnova’s Pan-European Accelerator
08:27 - China Biotechs
14:59 - Trump Tariffs
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
BIO is engaging with President Donald Trump to protect and improve FDA. It’s also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group.
BioCentury’s editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here.
View full story: https://www.biocentury.com/article/655370
00:00 - Introduction
02:09 - BIO's Trump 2.0 Plan
14:00 - Autoimmune CAR Ts
21:05 - Telix's Radiopharma Play
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
While the culling of companies in the biotech bear market may have yet to subside, creative cross-border deal-making on innovative assets is spreading across Asia’s Arc of Innovation. Sciwind Biosciences Co. Ltd.’s Jing Shu and A*Star’s Lisa Ooi join BioCentury to wrap up the 4th annual BioCentury-BayHelix East-West Biopharma Summit in Singapore by discussing deal-making trends, the rise of new technologies and the deepening of biotech ecosystems from India to Japan.
View full story: https://www.biocentury.com/article/655318
00:00 - Introduction
01:58 - Key Takeaways
08:42 - Innovation in Japan and India
12:54 - Building Biotech Ecosystems
31:14 - NewCo Model
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The almost certain confirmation of Marty Makary as FDA commissioner this month will cap a transition marked by internal upheaval and political infighting. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Thursday’s confirmation hearing for President Donald Trump’s pick to lead the agency and Makary's hints at what we can expect from his agenda.
The editors also discuss whether the advantages of amylin agonists could help the therapies outshine GLP-1 in obesity, why the latest weight loss data from CagriSema weighed on shares of Novo Nordisk, and a call to deliver on the meritocracy ideal, now that DEI is dead.
View full story: https://www.biocentury.com/article/655302
00:00 - Introduction
01:10 - Makary’s FDA Agenda
10:50 - Amylin in Obesity
24:21 - Life After DEI
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The track record of biotechs launched to create curative therapies using CRISPR-Cas9 provides new insights into the old debate over whether platform companies should validate their technology on established targets or pursue new ones. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the lessons learned by this small group of companies since their launch a decade ago. They also discuss the entrance of AbbVie into the obesity race via a $350 million deal with Gubra for a clinical stage amylin agonist — does it signal AbbVie’s belief in amylin monotherapy, or will the company be hunting for more obesity assets? The editors also talk about recommendations to streamline the early-stage development of rare disease therapies in the U.S.
View full story: https://www.biocentury.com/article/655214
00:00 - Introduction
00:36 - CRISPR Companies
09:22 - AbbVie Enters Obesity Race
17:19 - Rare Disease Drug Challenges
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Once pharma’s oncology powerhouse, Roche is charting a new course that extends beyond its traditional stronghold in cancer therapeutics. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the Swiss pharma has reshaped its strategy for long-term growth. They also discuss another tumultuous weekend for staff at FDA and NIH, as well as the challenges of precision medicine for psychiatric conditions.
View full story: https://www.biocentury.com/article/655157
00:00 - Introduction
00:45 - Roche Reboot
08:47 - Precision Medicine in Psychiatry
13:07 - 5 Things on Trump 2.0
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Rather than fretting over increasing competition from Chinese life sciences companies, biotechs in the U.S. should rise to the challenge and learn from their competitors. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the increasing pace of innovation from China and how U.S. biotechs need to meet the moment, delivering key takeaways from Editor in Chief Simone Fishburn’s fireside chat with industry leader John Maraganore at the BIO CEO & Investor Forum in New York last week. The team also discusses the fallout from staffing cuts at FDA — severely damaged morale among remaining staff and the potential for a higher approval bar, among others — leadership at the agency and the state of biotech IPOs on NASDAQ and in Korea.
View full story: https://www.biocentury.com/article/655112
00:00 - Introduction
00:58 - Competing with China
14:13 - FDA, NIH Staff Cuts
20:16 - Biotech IPOs
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Western VCs are paying more attention than ever to innovation emerging from Asia — from antibody-drug conjugates to bispecifics, AI and beyond — as the NewCo Model becomes the latest trend to bridge talent, assets and venture money across the Pacific and on to North America and Europe. On a special edition of BioCentury This Week podcast, a trio of leaders from Asia’s life sciences ecosystem — Khoo Shih of Singaporean investor ClavystBio, McKinsey & Company’s Anirudh Roy Popli and Wendy Pan of Goodwin and BayHelix — join the BioCentury team to set the stage for the fourth BioCentury-BayHelix East-West Biopharma Summit. They discuss the innovations driving the deal flow from East to West, including the creation of start-ups in the West formed around assets from Asia. The summit takes place March 3-5 in Singapore.
View full story: https://www.biocentury.com/article/655108
00:00 - Introduction
04:49 - The Newco Model and Industry Trends
09:13 - BayHelix and Cross-Border Transactions
11:31 - McKinsey's Perspective on Asian Innovation
26:58 - Final Thoughts and Registration Information
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
White House plans to slash FDA and NIH risk decimating two agencies at the core of U.S. biomedical innovation. On the latest BioCentury This Week podcast, BioCentury’s editors assess draft plans by the Trump administration that seek to halve FDA staff, cut NIH, and reduce overhead payments to academic institutions. The policy addressed in a recent Guest Commentary for BioCentury, “Defending the NIH, the NSF and the foundation of American science,” by the Scleroderma Research Foundation’s Luke Evnin, Peter Rubin of No Patient Left Behind, and Ra Capital’s Peter Kolchinsky.
BioCentury’s team also discusses how biotechs are becoming increasingly successful at navigating the obstacles to get precision therapies across the FDA finish line.
View full story: https://www.biocentury.com/article/655034
00:00 - Introduction
00:59 - FDA, NIH & Trump 2.0
16:26 - Biotechs & Precision Medicine
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The boom in the creation of companies that were launched in the West based on assets sourced in Asia signals China’s galloping speed of innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the “NewCo Model,” who the players are, from CEOs and companies to investors; the areas of innovation the start-ups are tackling; and the evolution of the trend. (Read about the company that kicked off the trend, Arrivent, here.)
The editors also assess how personnel losses at FDA from the Trump administration’s plans to slash government payrolls are likely to cause short- and long-term harm for the agency and the drug approval process. And a new pain therapy from Vertex is in the spotlight as the CF specialist enters new turf.
View full story: https://www.biocentury.com/article/654946
00:00 - Introduction
01:20 - Asia's NewCo Model
16:22 - FDA Tipping Point
20:27 - Vertex's Pain Drug
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Psychiatric drug development has had major wins over the past year-and-a-half — think Karuna Pharmaceuticals' $14 billion takeout by Bristol Myers Squibb and the subsequent launch of a new schizophrenia therapy — but targeted neuropsychiatric drug development is still in its infancy. On a special edition of the BioCentury This Week podcast, BioCentury’s editors detail the promise of precision medicine in the space and break down what recent setbacks for key players mean for next steps in the clinic. The team is joined by special guest Peter Schueler, SVP of drug development solutions, neurosciences, at ICON, who delivers takeaways from this month’s the ECNP Roadmap Meeting on Precision Psychiatry in Frankfurt and a recent white paper by ICON. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/654903
00:01 - Sponsor Message: ICON Biotech
02:20 - Precision Neuropsychiatry
06:39 - Insights from ICON's Peter Schueler
15:59 - Challenges in Neuropsych
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
BioCentury’s analysis of the technologies behind last year’s biotech series A raisers sees progress in nanoparticles, CAR cell therapies, degraders and antibody-drug conjugates. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trends spotted in 2024’s crop of more than 150 series A rounds — from top therapeutic areas and modalities to the leading investors funding the innovation.
The editors turn to Washington for takeaways from BioCentury’s “exit interview” with Patrizia Cavazzoni, the recently departed director of FDA’s Center for Drug Evaluation and Research, and checks in on FDA and NIH’s turbulent transition under Trump 2.0.
Finally, the podcast team previews BioCentury’s upcoming fourth East-West Summit, which will focus on globalizing Asia innovation and the red-hot “Newco Model” in Singapore March 3-5, and the twenty-fifth Bio€quity Europe, which will be held in Belgium in May. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/654837
00:01 - Sponsor Message: ICON Biotech
01:57 - Series As: Trends in Innovation
12:18 - BioCentury Conferences Preview
18:45 - Insights from FDA's Cavazzoni
21:58 - Turbulence at FDA, NIH
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
With political uncertainty overshadowing market sentiment going into 2025, BioCentury’s editorial team assesses the bull and bear arguments for biotech in the New Year on the BioCentury This Week podcast’s Public Markets Preview. Will continued uncertainty drive biotech sentiment in the coming months, or will the bear arguments fail to manifest, stymied by M&A and other positive factors?
In the second part of the 2025 Preview, BioCentury’s editors highlight some of the key catalysts in bispecifics, immunology and inflammatory (I&I), new modalities, and neurology and obesity they are watching in the year ahead. Finally, the editors discuss how VC firms focused on AI-driven drug development are thinking about the resources and strategies needed to turn promise into reality. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/654772
00:01 - Sponsor Message: ICON Biotech
02:33 - Market Uncertainty
12:50 - Biotech Catalysts
21:12 - Obesity
22:57 - Neurology
28:54 - AI: VC Perspectives
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Sunshine and a stream of deals brightened the mood at this year’s J.P. Morgan Healthcare Conference, offering a pleasant counterpoint to continued pessimism over the state of the capital markets. On the latest BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from biotech’s annual kick-off event from megarounds and Asian newcos to the new state of M&A and pending change at FDA.
View full story: https://www.biocentury.com/article/654723
00:00 - Introduction
01:52 - Market Sentiments and Deal Expectations
04:42 - Cross-Border Deals and Asia's Growing Influence
07:12 - Neurology and Innovation in Biotech
14:44 - VC Trends and Megarounds
20:00 - Upcoming East West Singapore
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
J&J’s $14.6 billion takeout of neurology play Intra-cellular Therapies headlined a buzzy start to the J.P. Morgan Healthcare Conference, where a flurry of deal announcements recalled the conference’s pre-pandemic days. On the latest BioCentury This Week podcast, BioCentury's editors discuss the takeout of Intra-cellular, the third 11-digit neuro M&A in the past 13 months, as well as M&A involving Idrx and GSK, and Scorpion Therapeutics and Eli Lilly. Turning to Washington, the team explores what’s behind BIO CEO John Crowley’s visit to Mar-a-Lago to meet with President-elect Donald Trump, impending changes at FDA under Trump 2.0 and key takeaways from Rep. Jake Auchincloss appearance on BCTW’s sister podcast, The BioCentury Show. The team also breaks down the key trends in the past year in FDA approvals. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/654694
00:01 - Sponsor Message: ICON Biotech
02:38 - JPM Deal Buzz
11:20 - Washington Update
16:08 - Rep. Auchincloss’ Take on Biopharma
21:01 - FDA Regulatory Decisions
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Can biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury’s editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn’s latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients.
Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year’s worth of wrangling over the Biosecure Act, and Executive Editor Selina Koch breaks down readouts from Neumora on its KOR antagonist navacaprant to treat major depressive disorder and Axsome Therapeutics for its AXS-05 to treat agitation in Alzheimer’s patients. This episode of BioCentury This Week was sponsored by ICON Biotech.
View full story: https://www.biocentury.com/article/654620
00:01 - Sponsor Message: ICON Biotech
01:51 - Biotech's Repeating Challenges
10:52 - Biotech in the New Year
23:07 - Beyond Biosecure
28:10 - Neurology Readouts
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound.
View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast
00:00 - Introduction
02:03 - Bob Temple's Legacy
16:13 - China's Academic Innovation
26:20 - CagriSema Obesity Data
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.
The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/653858
00:00 - Introduction
03:01 - Capital Markets Outlook
06:01 - M&A
15:19 - Breaking Down Deals
24:29 - Asia
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Lately, it appears some biotech VCs have hit a ceiling, capping their new funds at or below the amount of their previous vehicles, says Paul Bonanos on the latest BioCentury This Week. Bonanos and his BioCentury editorial colleagues discuss what’s behind the trend as they assess VC fundraising in this post-‘supercycle’ era. The editors also evaluate the state of play for venture-backed obesity plays and which VCs are active in the space, as well as takeaways from the latest BioCentury Show podcast featuring Aoife Brennan, CEO of Climb Bio. Finally, the team features the new book from long-time biotech executive and current SV Health Investors partner Tim Harris, In Pursuit of Unicorns: A Journey through 50 Years of Biotechnology.
View full story: https://www.biocentury.com/article/654488
00:00 - Introduction
02:08 - Trends in VC Funds
12:16 - Obesity Start-ups
19:46 - The BioCentury Show with Aoife Brennan
26:50 - Tim Harris' New Book: In Pursuit of Unicorns
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now.
View full story: https://www.biocentury.com/article/654420
00:00 - Introduction
01:42 - Biosecure Setback
10:01 - Novartis' $1B PTC Deal
16:28 - KCC2 Activation
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.
The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval.
View full story: https://www.biocentury.com/article/654363
00:00 - Introduction
01:08 - Trump's NIH Pick
12:13 - Multi-targeted CAR Ts
19:26 - Biotech FDA Approvals
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.
View full story: https://www.biocentury.com/article/654319
00:00 - Introduction
00:32 - Jefferies Conference Takeaways
06:25 - Trump Nominations
17:41 - Biosecure Act Update
21:01 - Pharma in Obesity
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Giving RFK Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor’s Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way.
BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment, and the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: BioNTech's acquisition of Biotheus, and Merck's licensing of global rights to a LaNova asset.
View full story: https://www.biocentury.com/article/654233
00:00 - Introduction
01:12 - RFK Jr. & HHS
13:15 - Blenrep's Comback
19:25 - China Deals
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.
BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what’s known about the allegations and whether the situation could affect other MNCs operating in the country.
View full story: https://www.biocentury.com/article/654157
00:00 - Introduction
01:01 - Prepping for Trump
09:41 - Alzheimer's Ethics
17:44 - AstraZeneca's Challenges in China
21:51 - Myths and Misperceptions
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.
BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.
View full story: https://www.biocentury.com/article/654075
00:00 - Introduction
01:23 - CTAD: Anti-amyloids
14:22 - CTAD: UCB's tau data
19:47 - FDA & the Election
28:16 - China Summit Debrief
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Twenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury’s editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren’t limited to cancer, but are also playing out in other settings such as immunology.
The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom agreed a major role of the FDA commissioner is to protect the agency from political interference.
Washington Editor Steve Usdin also previews his conversation with FDA’s Richard Pazdur, and Editor in Chief Simone Fishburn details takeaways from her Q&A with James Sabry, who recently became CBO at BioMarin Pharmaceutical.
View full story: https://www.biocentury.com/article/653926
00:00 - Introduction
00:38 - EGFR Case Study
08:45 - FDA Commissioners & Politics
19:19 - James Sabry's Timeline
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Cross-border geopolitical tensions and a prolonged capital crunch are compelling biopharma companies from Beijing to Boston to rethink their strategies on everything from deal-making and raising capital to manufacturing and use of CROs. On a special edition of the BioCentury This Week podcast, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s eleventh annual BioCentury-BayHelix China Healthcare Summit in Shanghai to discuss the dynamics affecting biotechs in China looking beyond the country’s borders and Western biopharma companies seeking innovation and partners in China, as well as the latest trends, such as U.S. VCs and/or management teams building newcos around China assets. They also detail highlights among the three-day event’s speakers, panels and fireside chats.
The BioCentury-BayHelix China Healthcare Summit will take place Oct. 30 through Nov. 1 at the St. Regis Shanghai Jian in Shanghai. For information on registering to attend and/or becoming a presenting company, click here.
View full story: https://www.biocentury.com/article/653959
00:00 - Introduction
03:32 - The View from BayHelix
06:59 - The View from McKinsey
18:57 - Summit Highlights
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
At least 25 venture firms have raised a total of more than $17 billion in funds this year, with Forbion unveiling the largest-ever European biopharma fund at €1.2 billion last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Forbion deployed its prior fund and quickly raised fresh funds and what that — and other funds — say about the state of financing private biotechs in Europe and elsewhere.
The editors then assess takeaways from BioCentury’s conversation with NIH’s Daniel Reich on data that could shape drug development’s future for progressive multiple sclerosis, and neurodegeneration broadly, as well as how the first clinical data from an RNA-editing oligonucleotide therapy from Wave Life Sciences demonstrate that it’s possible to change a single base in an RNA to correct a disease-causing mutation in patients.
View full story: https://www.biocentury.com/article/653924
00:00 - Introduction
02:48 - VC Funds
11:50 - New Chapter for MS
23:48 - Wave's Data
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
There is a growing mandate among researchers and VCs to provide proof of causal human biology for new targets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the different strategies being deployed to identify causal links to disease using observational patient data or human cell models, including the challenges that come with each approach and the various computational methodologies companies are using.
They also discuss the outcome of FDA’s advisory committee meeting on Barth syndrome candidate elamipretide from Stealth Biotherapeutics, and the implications of the discussion for review of ultrarare disease therapies more broadly.
Diving into the deal of the day, the editors review the proposal by H. Lundbeck to acquire Longboard Pharmaceuticals for $2.6 billion, and discuss how the biotech’s therapy for developmental epilepsies may stack up against competitors.
View full story: https://www.biocentury.com/article/653843
00:00 - Introduction
00:34 - Causal Biology and Big Data
17:52 - FDA's Ultra-Rare Decision
27:29 - Lundbeck Acquires Longboard
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Biopharma buysiders and bankers at long last believe the conditions are ripe for biotech growth and outperformance, BioCentury’s Stephen Hansen says on the latest BioCentury This Week podcast. Hansen and colleagues take stock of the sector’s growth potential after three long years of the bear market as they discuss BioCentury’s 4Q24 Public Markets Preview.
Also on this week’s show, Washington Editor Steve Usdin discusses his Editor’s Commentary, in which he argues that FDA leaders planned reforms for its advisory committee process fall far short of what they need to do.
Usdin then delivers takeaways from the most recent edition of BioCentury This Week’s sister podcast, The BioCentury Show, which features a behind-the-scenes look at CMS’s anti-amyloid mAb decision-making process with Lee Fleisher, the former CMO of the agency.
Finally, BioCentury’s Josh Berlin joins the podcast to preview the eleventh annual BioCentury-BayHelix China Healthcare Summit, which runs Oct. 30 to Nov. 1 in Shanghai. The theme of this year’s conference, which features panels of pharma BD&L leaders and blue chip investors as well as a lineup of presenting companies, is reinventing your China strategy.
00:00 - Introduction
02:13 - 4Q Public Markets Preview
16:16 - What's on at the China Summit
28:25 - Fixing FDA's Advisory Panels
34:09 - Recap: The BioCentury Show with Lee Fleisher
View full story: https://www.biocentury.com/article/653793
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Approval of BMS’s first-in-class schizophrenia drug is good news for patients and the company’s thinning pipeline alike, but maximizing Cobenfy’s commercial potential depends on readouts in additional indications. On the latest BioCentury This Week podcast, BioCentury’s editors assess the significance of the new therapy and what the pharma needs to do to make its launch a success.
They also discuss the impact of the withdrawal of Pfizer's sickle cell therapy; the work left unfinished on biotech-related legislation in Congress; BioAge's NASDAQ IPO; and the importance of FDA’s Oncologic Drugs Advisory Committee meeting on the use of PD-1 inhibitors in patients with certain tumors expressing low levels of PD-L1. This episode of BioCentury This Week was sponsored by Parexel Biotech.
View full story: https://www.biocentury.com/article/653732
00:01 - Sponsor Message: Parexel BioTech
01:41 - BMS Schizophrenia Drug
12:28 - Pfizer Withdrawal's Oxbryta
18:26 - ODAC and PDL1
23:56 - D.C. Update
26:51 - BioAge IPO
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism’s past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from this year’s meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what’s changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech.
View full story: https://www.biocentury.com/article/653681
00:01 - Sponsor Message: Parexel BioTech
01:55 - iTeos' TIGIT Data
04:56 - Rybrevant Colorectal
07:22 - Gwyn Bebb's Take
21:38 - More ESMO Highlights
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Rep. Frank Pallone’s misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it’s valuable to the country’s youngest patients, as well as to small biotechs and larger biopharma alike.
Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury’s Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value for the Danish pharma. This episode of BioCentury This Week was sponsored by Parexel Biotech.
View full story: https://www.biocentury.com/article/653633
00:01 - Sponsor Message: Parexel Biotech
01:47 - Pediatric PRVs
06:42 - Biosecure Act
12:44 - Novo's Obesity Miss
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from the debut Grand Rounds conference, which focused on whether biotech can write a more successful playbook for translating from target to product. Weaving together takeaways from the panels, fireside chat and keynote at the conference, the editors assess the tensions between generalizability and fit-for-purpose models, between having control and capturing complexity, and, in human data, between scale and robustness/reliability, particularly for longitudinal readouts. The editors also discuss BioCentury's Q&A with USC Keck School’s Patrick Lyden, who explained how high-quality, reproducible preclinical science can be feasible.
View full story: https://www.biocentury.com/article/653631
00:00 - Introduction
02:56 - Generalizability vs. Fit for Purpose
10:03 - Control vs. Complexity
17:57 - Scale vs. Robustness in Human Data
26:25 - Hypothesis-Driven vs. Unbiased Research
28:50 - Grand Rounds 2025
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
On the latest BioCentury This Week podcast, BioCentury’s editors assess the shifting market for biotech IPOs, including the profiles of the three companies that went public on NASDAQ last week, the aftermarket performance of the year's IPO class, and the prospects for more companies to make their own debut in the coming months. BioCentury’s editors also discuss whether the rush to GLP-1s for obesity will mirror the development of PD-1s for cancer and the impact on biopharma of the recent mainstream expansion of AI. This episode of BioCentury This Week was sponsored by Parexel Biotech.
View full story: https://www.biocentury.com/article/653538
00:01 - Sponsor Message: Parexel Biotech
01:30 - IPOs
10:56 - GLP-1 & Obesity
22:18 - AI & Biotech
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Will bispecifics be the drugs to dethrone cancer’s biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest data from Akeso’s ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer.
The editors also discuss data from Vaxcyte that the infectious disease company parlayed into the year’s largest follow-on financing and a new initiative by FDA veteran Janet Woodcock to bolster quality in biopharmas’ manufacturing. This episode of BioCentury This Week was sponsored by Parexel Biotech.
View full story: https://www.biocentury.com/article/653507
00:01 - Sponsor Message: Parexel Biotech
01:39 - Akeso's Bispecific Challenge
08:22 - Vaxcyte Pneumococcal Vaccine
12:32 - Woodcock's Quality Initiative
14:48 - Recap: The BioCentury Show on Biosimilars
In this year’s series of Back to School essays, BioCentury’s editors ask whether the era of human first, causal biology and personalized medicine can reshape drug discovery to solve the weakest link in biotech — translation to the clinic. On a special edition of the BioCentury This Week podcast, the three authors of BioCentury’s 32nd Back to School edition, Editor in Chief Simone Fishburn, Executive Editor Selina Koch, and Executive Director of Biopharma Intelligence Lauren Martz, discuss how industry can solve its biggest bottleneck.
The editors zero in on inflammation and immunology, specifically how immunoproteomics upstage genomics in I&I target discovery, and neurology, notably how neuroscience companies are reducing to practice the concept of human-first discovery. Finally, they discuss the thread that runs through it all — precision medicine — and how biomarkers can help validate targets while bringing precision medicine to I&I and neurology.
View full story: https://www.biocentury.com/article/653485
00:00 - Introduction
01:32 - Introducing Back to School
10:42 - Validation Tools
14:50 - I&I
21:00 - Neurology
27:19 - Precision Medicine
A vote on the Biosecure Act in the U.S. House of Representatives early next week shines the spotlight back on legislation seeking to rein in Chinese CDMOs and genomics companies, as Congress returns to work. On the latest BioCentury This Week podcast, BioCentury’s editors handicap the legislation’s chances of passage in the House and Senate and assess what’s at stake for the law authorizing rare pediatric disease priority review vouchers.
They also discuss the results of BioCentury’s snap poll gauging the biopharma industry’s reaction to the IRA Medicare drug price negotiation program, recalling the latest trends among pharma’s deals with biotechs over the past 12 months. Plus, a preview BioCentury’s annual Back to School package, next week’s new Grand Rounds R&D conference and highlights from this month’s Distillery roundup of translational papers.
View full story: https://www.biocentury.com/article/653385
00:00 - Introduction
01:36 - Biosecure on Deck
04:33 - Priority Review Vouchers
08:11 - BioCentury IRA Survey
17:07 - Back to School: Target Discovery
19:49 - Translational Highlights
Shaking up an underwhelming year for fresh biotech paper, a trio of biotechs filed to go public on NASDAQ last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the IPO filings by MBX and Massachusetts companies Zenas and Bicara. Washington Editor Steve Usdin returns to the podcast to provide updates on the Inflation Reduction and Biosecure acts, as well as the life sciences policies of presidential candidates Donald Trump and Kamala Harris. And Director of Biopharma Intelligence Karen Tkach Tuzman zeroes in on the latest trends among pharma’s deals with biotechs over the past 12 months and the latest start-up out of Versant Ventures, Borealis.
View full story: https://www.biocentury.com/article/653354
00:00 - Introduction
01:48 - Biotech IPOs
12:48 - Washington Update
20:39 - Versant, Novartis Newco
24:34 - Pharma-Biotech Deal Trends
Grand Rounds is an R&D meeting that represents BioCentury’s latest initiative to create new networks linking academic discoveries with translational skills and the investors who will finance them, BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the new conference. The meeting, on Sept. 9-11 in Nashville, focuses on whether biotech can write a more successful playbook for translating from target to product.
The podcast features three special guests who will be at the conference: McKinsey's Guang Yang, Candel Therapeutics' Paul Peter Tak, and Abby Trotter of Life Science Tennessee. There is still time to register for BioCentury Grand Rounds, which will take place Sept. 9-11 in Nashville. Network, partner and debate key bottlenecks in translation. See the conference website for more information.
View full story: https://www.biocentury.com/article/653324
00:00 - Introduction
00:13 - Spotlight Grand Rounds
02:03 - Conference Themes
08:40 - Nashville's Biotech Ecosystem
16:58 - Paul Peter Tak on I&I
25:22 - McKinsey Report Preview
The Biden administration has disclosed what Medicare will pay for the first graduates of its drug price negotiation program but biopharma companies, biotech investors and patient advocates are still waiting for the government to reveal how those prices were determined — details that are critical to informing the decisions that will shape the future of medicine. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what last week’s disclosure tells us — and what information is yet to come.
They also discuss why psychedelics companies believe they can avoid the hurdles that tripped up Lykos Therapeutics as it sought approval of its MDMA program to treat post-traumatic stress disorder (PTSD), and preview this year’s BioCentury Back to School report, which focuses on whether biotech can write a more successful playbook for translating from target to product.
Take part in BioCentury’s Snap Survey on the IRA and Part D pricing. We’ll be publishing the results next week, which means we need your input now! All results will be anonymous.
View full story: https://www.biocentury.com/article/653298
00:00 - Intro
01:32 - Medicare Drug Pricing
11:38 - Psychedelic Setback
18:53 - Back to School Preview
Pharmaceutical companies and some investors may have once again become wary of gene therapy, but the modality’s future is bright, according to Jim Wilson. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from BioCentury’s exclusive interview with the AAV trailblazer, including Wilson’s prediction that the benefits of the therapies will extend beyond rare genetic diseases, and the rationale for his new therapeutics company, Gemma Biotherapeutics.
BioCentury’s head of corporate alliances & business development, Josh Berlin, then joins the podcast team to detail the challenges and opportunities for biotech in South Korea, and to preview some of the highlights of the upcoming Grand Rounds conference. The event, BioCentury’s first R&D conference, takes place Sept. 9-11 in Nashville, Tenn. and tackles the roadblocks in the translation of science into new medicines.
View full story: https://www.biocentury.com/article/653239
00:00 - Intro
01:31 - Wilson’s Vision for Gene Therapy
14:23 - Inside Korea's Biotech
21:45 - BioCentury's Grand Rounds
A substantial part of the biopharma ecosystem involves deals between biotechs and academics, with smaller companies accessing assets to add to their pipelines and technologies to help solve problems. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the interplay of biotech and academia, including how deals between the groups often come outside the hubs of Boston and the Bay Area and what types of indications and technologies are common focus points. They also discuss new data in Alzheimer’s for Leqembi from Eisai and Biogen that provide insight into how to get the most out of anti-amyloid mAbs for the disease, and what’s next for James Wilson now that the gene therapy pioneer is moving on from the University of Pennsylvania.
View full story: https://www.biocentury.com/article/653174
00:00 - Intro
04:25 - Biotech-Academia Deals
12:04 - Leqembi's Latest Data
19:20 - What's Next for James Wilson
Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.
View full story: https://www.biocentury.com/article/653010
02:06 - CHMP Leqembi Decision
09:53 - Perioperative Cancer
17:45 - Pediatric Review Vouchers
23:55 - Beyond Biosecure
Alpha emitters are the latest trend in the hot radioligand space, but there’s debate about which isotope offers the best attributes for optimizing safety and efficacy. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the benefits and challenges that come with developing radiopharmaceuticals using lead-212 versus its more well-known counterpart actinium-225. They also discuss Editor-in-Chief Simone Fishburn’s conversation with Susan Galbraith, EVP of Oncology R&D at AstraZeneca, the latest innovations in delivering lipid nanoparticles to specific tissues beyond the liver, and the most recent oral GLP-1 obesity data from Roche.
View full story: https://www.biocentury.com/article/653008
00:00 - Intro
05:36 - Radiopharma Alpha Emitters
12:18 - AZ’s Susan Galbraith
21:40 - Lipid Nanoparticles
25:22 - Oral GLP-1 Race
Buysiders are upbeat headed into the back half of the year, but uncertainty over the Federal Reserve’s timing on interest rate cuts is keeping that sentiment in check. On the latest BioCentury This Week podcast, BioCentury’s editors preview the public markets’ second half of 2024, discussing the appetite for biotech IPOs and M&A and what investors are looking for as they read the Fed tea leaves.
They also discuss Congress’ FDA budget squeeze, the growing momentum of the Biosecure Act — which seeks to rein in Chinese CDMOs and genomics companies in the U.S. — and the legacy of IR/PR pioneer Lisa Burns, who passed away this month after spending years advising biotech CEOs and investors.
View full story: https://www.biocentury.com/article/652968
00:00 - Intro
02:54 - 3Q Markets Preview
12:33 - Policy Update
18:40 - Remembering Lisa Burns
The U.K.’s life sciences ecosystem boasts “palpable energy at the very innovation end of the spectrum in biotech, with a lot of really quality science,” BioCentury Editor in Chief Simone Fishburn says on the latest BioCentury This Week podcast. Fishburn assesses the maturation of the country’s biotech industry, including the need for an influx of capital to catalyze the sector’s growth. Washington Editor Steve Usdin discusses the latest developments for the Inflation Reduction and the Biosecure acts as well as the benefits of the breakthrough therapy pathway. Also on BioCentury.com, listeners may want to check out Danielle Golovin’s analysis of LNP innovation and Paul Bonanos’ take on Monday’s $3.2 billion M&A move by Eli Lilly. This episode of BioCentury This Week was sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652898
00:01 - Sponsor Message: Nxera Pharma
01:24 - U.K. Biopharma
08:14 - IRA
10:28 - Biosecure Act
14:49 - Breakthrough Designation Pathway
The impact on FDA and the biopharma industry of the Supreme Court’s move to overturn the legal doctrine that courts defer to federal agencies’ interpretations of ambiguous laws will take years to come into focus; for now, the clearest effects of the Chevron ruling will be on disputes over exclusivity and other non-science issues. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the court’s decision, including how FDA could adjust how it operates. The editors also discuss tumor cell surface targets off the beaten path, and BioCentury’s Q&A with Lurie Prize winner Howard Chang about how his lab, and the five companies he has co-founded, have turned serendipitous discoveries about poorly understood nucleic acid types into translational strategies. This episode of BioCentury This Week was sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652845
00:01 - Sponsor Message: Nxera Pharma
04:49 - Chevron Ruling's Impact
10:32 - Tumor Cell Surface Targets
15:48 - Lurie Winner: Howard Chang
A biomarker breakthrough could shave years off the development of therapies for a group of devastating, progressive ultrarare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss FDA’s agreement to allow biopharma companies to use a biomarker as the basis for accelerated approval of neuronal mucopolysaccharidoses therapies, which marks an important inflection point, both for MPS and rare diseases in general. The editors also assess FDA’s decision to grant full approval to and expand the label of Sarepta DMD gene therapy Elevidys delandistrogene moxeparvovec, igniting another controversy over the agency's decision-making; discuss how human genetics is promising to remove some of the risk from neurology drug development; and preview BioCentury’s new conference, Grand Rounds, which takes place in September in Nashville, at the interface of academia and industry. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652789
00:01 - Sponsor Message: Nxera Pharma
02:05 - Introducing BioCentury's Grand Rounds
06:46 - An MPS Breakthrough
14:12 - Sarepta Approval
After whisking through Washington for the first half of the year, raising alarms, mutating and causing confusion, the Biosecure Act is now on pause. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the delay for the legislation, which seeks to drive Chinese contract development and manufacturing organizations out of the U.S., means, what will happen next, and how it will impact life sciences companies.
View full story: https://www.biocentury.com/article/652771
03:09 - What's In, What's Out
05:41 - Broader Impact
11:07 - Wake-up Call
The avian flu outbreak is a fire drill that is showing how poorly the U.S. is prepared for the next pandemic. On the latest BioCentury This Week podcast, BioCentury's editors recap last week’s BioCentury Show conversation with Rick Bright, including the former BARDA director’s insights on the opportunities for biotechs to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics and the need for the government to provide leadership and funding to empower industry. They also discuss new SEC rules that will make reverse mergers less attractive; the Supreme Court’s mifepristone ruling and a trio of neuro-focused stories -- one on FDA’s guidance on presymptomatic Alzheimer’s, another on an advisory committee’s discussion about Eli Lilly's anti-amyloid therapy donanemab and a third focused on what neuroscience biotech companies need to consider when pitching VCs and pharmas. This week’s podcast is sponsored by Nxera Pharma.
0:01 - Sponsor Message: Nxera Pharma
01:40 - Pandemic Prep Problems
11:11 - Reverse Mergers
15:43 - Alzheimer's
25:31 - SCOTUS
BIO’s annual meeting took place amid heightened industry concerns regarding the Biosecure Act, which took yet another unexpected turn this week. On a special edition of the BioCentury This Week recapping the meeting, BioCentury's editors discuss the latest on the anti-China biopharma legislation, including misperceptions of what the bill seeks to accomplish.
Special guest Chris Cargill, the CEO of Nxera Pharma, joins the podcast to discuss the expanded APAC presence at this year’s BIO; Japan’s push to build the biotech ecosystem in the country; and how Nxera (formerly Sosei) is evolving. And finally, BioCentury’s editors deliver the takeaways from Karen Tkach Tuzman’s BIO panel focused on radiopharmaceuticals, including debate on the merits of long- versus short-lived radioisotopes. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652686
00:01 - Sponsor Message: Nxera Pharma
02:34 - BIO Wrap: Biosecure
09:12 - Japan & Nxera
18:52 - Radiopharma
A snub by an FDA advisory committee for an MDMA-psychotherapy combination is unlikely to read through to other psychedelic therapies in the pipeline. On the BioCentury This Week podcast, BioCentury’s editors discuss the shortcomings of the Lykos Therapeutics product’s clinical development program and why other psychedelics likely won’t face the same hurdles. The editors also assess FDA’s new platform technology designation and the first-in-human clinical trials described at this year’s American Society of Clinical Oncology (ASCO) meeting. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652639
00:01 - Sponsor Message: Nxera Pharma
01:41 - Psychedelic Setback
12:38 - FDA's Platform Play
21:39 - ASCO Innovations
Four takeouts with upfront payments north of $1 billion to close out May mark the latest run of VC exits from biotech M&A and help expand the pipelines of large biopharmas in renal, ophthalmic and immunologic indications. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how two of the takeouts -- Asahi Kasei’s buy of Calliditas and Biogen’s acquisition of HI-Bio -- showcase how the renal field is on the rise. Turning to Washington, the editors explain why the House Select Committee on the Chinese Communist Party is expanding its remit to Chinese therapeutic developers and commercial competitiveness — with an initial focus on Legend and GenScript. And, finally, they assess data from ASCO that demonstrate how immunotherapies are making progress in “cold” colorectal cancers. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652597
00:01 - Sponsor Message: Nxera Pharma
1:35 - Biotech M&A
11:40 - Biosecure Act
23:00 - ASCO
A theme among late-breaker presentations at this year’s American Society of Clinical Oncology meeting is the push by companies to move targeted therapies into earlier lines of treatment. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what they’re watching for in ASCO’s headline presentations and deliver highlights from abstracts released late last week as the oncology meeting readies to kick off on Friday. The editors also discuss the interest by FDA’s Janet Woodcock in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for ALS, and Biogen's $1B+ acquisition of HI-Bio. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652531
0:01 - Sponsor Message: Nxera Pharma
1:43 - ASCO
6:46 - Ultrarare Diseases
14:52 - FNIH's ALS Push
20:27 - Biogen M&A
New BIO CEO John Crowley is reorganizing BIO in a bid to reshape how the organization communicates and enhance its focus on patients. BioCentury’s editors also recap the 24th annual Bio€quity Europe conference that was held in San Sebastián, Spain last week, as well as highlights from last week’s American Society of Gene and Cell Therapy conference. The editors also discuss impressive early data from Endeavor BioMedicines in idiopathic pulmonary fibrosis and Phase Ib obesity data from Roche. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652453
0:01 - Sponsor Message: Nxera Pharma
1:08 - BioEquity Europe recap
7:08 - Shake up at BIO
13:37 - ASGCT highlights
20:39 - Endeavor IPF data
22:20 - Roche obesity data
“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions.
The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652427
00:00 - The BioCentury Show Podcast
01:51 - Lowe’s Blog
05:30 - Biosecure Act
09:53 - AI & Drug Discovery
17:33 - FDA, The Abortion Drug, & Aduhelm
22:05 - Lessons from COVID
Lawmakers’ changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what’s next for the legislation, plus how WuXi AppTec is defending itself against the bill’s allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week’s surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder’s Zenas BioPharma, as well as recent deals of note, including one for Maze Therapeutics. The biotech found a new partner for its Pompe disease program in Shionogi, months after Sanofi pulled out of a deal for the therapy amid FTC scrutiny. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652402
00:01 - Sponsor Message: Nxera Pharma
03:24 - Biosecure Revisions
09:34 - WuXi AppTec Responds
14:42 - Venture Raises
19:32 - Deals of Note
It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important."
The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652294
00:00 - The BioCentury Show Podcast
02:12 - Spain’s Biotech Ecosystem
10:06 - Investment Criteria
15:03 - ESG, Diversity
28:29 - AI in Drug Development
Next week's Bio€quity Europe conference in San Sebastián will focus on how European biotechs can rise above the noise to attract investors, partners and talent. McKinsey & Co.’s Alexandra Zemp and Paula Olazábal of Ysios Capital joined BioCentury to outline the opportunities and challenges faced by Spain’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. EBD Group's Claire Macht also joined to detail what to expect in terms of attendees and one-on-one partnering meetings at the event. Bio€quity Europe 2024 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.
View full story: https://www.biocentury.com/article/652371
00:00 - Intro
03:27 - Spanish Biotech Ecosystem
08:13 - McKinsey's Insights
12:08 - Event Preview
17:26 - BioЄquity Europe C-Level Attendees
One of the big themes of this week’s ASGCT meeting will be CAR T cells in cancer and beyond. On the latest BioCentury This Week podcast, BioCentury’s editors preview the American Society of Gene and Cell Therapy’s annual meeting. Much of the CAR T field has reoriented from cancer to autoimmune diseases over the past year. Now, researchers are looking even farther afield. According to abstracts released ahead of ASGCT, the engineered T cell modality may have new benefits to offer patients with asthma, Duchenne muscular dystrophy or HIV.
The editors also discuss a study aiming to quantify the benefits accelerated approval has had for cancer patients, and what’s next for the Biosecure Act and similar legislation seeking to rein in Chinese CDMOs and genomics companies. This week’s podcast is sponsored by Nxera Pharma.
Don’t miss BioCentury’s new podcast, The BioCentury Show, featuring BioCentury one-on-one with an industry KOL. It’s available wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652335
00:01 - Sponsor Message: Nxera Pharma
01:43 - ASGCT Preview
10:37 - BioCentury Show Podcast
14:21 - Accelerated Approval
19:48 - Biosecure: What’s Next
Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/652273
0:01 - Sponsor Message: Jeito Capital
1:55 - Energizing Gene Therapy
6:28 - Pfizer Hemophilia Approval
11:36 - Bio€quity Europe Preview
18:03 - Arch & Foresite's AI Biotech Build
19:32 - Ono's Deciphera Takeout
A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary.
BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/652185
0:01 - Sponsor Message: Jeito Capital
1:54 - Defending Accelerated Approval
8:44 - Endpoint Innovation
12:55 - Challenges for U.K.'s AIM
18:16 - Obesity Launch: Metsera
Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and the likely key factors for CMS as it determines prices for the first cohort of drugs in Medicare drug price negotiations under the Inflation Reduction Act. They also preview BioCentury’s first R&D conference — Grand Rounds — which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville, Sept. 9-11. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/652107
0:01 - Sponsor Message: Jeito Capital
1:30 - Introducing BioCentury's Grand Rounds
3:59 - Vertex’s Alpine Takeout
9:38 - Goldman’s Venture Strategy
14:33 - Reading the IRA Tea Leaves
M&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for Cancer Research and the editors’ insights on why degrader-antibody conjugates are emerging as the next contenders to build on the success of the antibody-drug conjugates paradigm. Editor in Chief Simone Fishburn also previews Grand Rounds, BioCentury’s first R&D conference, which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville Sept. 9-11. To learn more about BioCentury Grand Rounds and opportunities to present, see the conferencewebsite. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/651996
0:01 - Sponsor Message: Jeito Capital
1:15 - Introducing BioCentury's Grand Rounds
3:53 - 2Q Markets Preview
12:48 - AACR Takeaways
15:46 - ADCs & DACs
Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why the court’s pending decision could safeguard FDA from judicial second-guessing. The team also analyzes the agency’s first ever complete response letter for lack of confirmatory trial enrollment. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/651937
0:01 - Sponsor Message: Jeito Capital
4:15 - Biotech IPOs
7:50 - Avalon BioVentures
11:14 - FDA at SCOTUS
16:29 - Confirmatory Trials
Bills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the measures.
They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with Atlas Venture’s Bruce Booth, and lessons from Orchard Therapeutics on what it takes to get FDA’s approval for an ultrarare disease drug.
For BioCentury’s complete coverage of the Biosecure Act and similar legislation in Senate, visit the Hot Topics page for the topic
Putting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever.
BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support a pair of BCMA-directed CAR T cell therapies in earlier lines to treat multiple myeloma, and what’s needed to help avoid deaths during the period while patient wait for the CAR T cells to be produced.
A congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington.
Plus: Editor in Chief Simone Fishburn argues that the future of diversity should not be bound up in the fate of DEI. And BioCentury's editors discuss the pivotal trial setback for Amylyx in ALS and what may be on FDA’s agenda as is schedules an advisory meeting for Lilly's Alzheimer's therapy donanemab.
The $3 billion raised by biotechs in a series of follow-ons and PIPEs last week marked another strong showing for a sector seeking to outrun the bear market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of fundraising for biotechs and their performance in the after-market. They also preview a forthcoming analysis of preclinical papers published in the Distillery, BioCentury’s coverage of translational science, describe the latest on anti-China bills in Congress and Inflation Reduction Act litigation, and discuss Closed Loop Medicine’s program that seeks to bring precision medicine to obesity.
Asia’s emerging “Arc of Innovation” spans from China, Japan and South Korea through the turf-neutral gateway of Singapore and west to India, with the ecosystems of these countries contributing to the arsenal of therapeutics and diagnostics that benefit patients globally.
On a special edition of the BioCentury This Week podcast, Aslan’s Carl Firth, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s BioCentury-BayHelix Biopharma Summit in Singapore to discuss innovation across Asia, rising East-West deal flow and the opportunities and challenges faced by the region’s various biotech ecosystems. They also detail highlights among the speakers, panels and fireside chats of the three-day event.
Join BioCentury, BayHelix and McKinsey March 4-6 in Singapore or virtually for the third East-West Biopharma Summit.
Arch Venture Partners’ Bob Nelsen is excited about AI’s potential in biotech and convinced the U.S. healthcare system could do a far better job delivering on the promise of the biopharma industry’s innovations. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from Nelsen’s appearance on The BioCentury Show, including how the longtime investor in China’s life sciences sector has adopted a more cautious stance on the country given increasing geopolitical tensions. BioCentury’s editors also discuss whether TL1A inhibitors are poised to bring precision medicine to large inflammatory and autoimmune indications, and why participants in a Feb. 21 Reagan-Udall Foundation workshop hope the meeting could help establish precedents that will revitalize the development of effective treatments for extremely rare diseases.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
Off switches and non-viral delivery technologies may be the solution to CAR T therapies’ most recent safety problem. On the latest BioCentury This Week podcast, BioCentury’s editors discuss alternative CAR T technologies already in development that avoid or reduce the risk of secondary malignancy.
The editors also discuss the world-first approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, highlights from BioCentury’s most recent survey of the translational literature in the Distillery, and the path to approval for Sarepta's Elevidys delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
Anti-China biotech bills are raising alarms at U.S. biotechs, with CEOs worried they could lose access to CDMOs WuXi AppTec and WuXi Biologics, and that legislation could imperil collaboration with Chinese companies more broadly. BIO has warned Congress the bills “would immediately and negatively” affect the U.S. biotech ecosystem. On this special edition of the BioCentury This Week podcast BioCentury Washington Editor Steve Usdin and colleagues discuss the pending legislation.
Innate immunity is getting another shot at cancer through antibody-drug conjugates, with immunostimulatory antibody-drug conjugates moving from concept to clinical product. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the therapies work and what sets them apart from conventional ADCs.
The editors also survey the companies developing psychedelic therapies that aim to overcome the difficulties of the business model, and assess Gilead's $4.3 billion takeout of liver disease company CymaBay, and the performance of IPOs by genomic editing tools company Metagenomi and immunology company Kyverna.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
As it approaches a steep patent cliff, Bristol Myers is charting its course to bridge a transition period and return to growth. On the latest BioCentury This Week podcast, BioCentury’s editors assess the pharma’s pipeline and recent M&A, outlining the clinical and commercial successes the company needs to navigate the next few years.
The editors also discuss what’s behind bills in Washington that target four Chinese companies identified by Congress as “biotechnology companies of concern," the latest biotech IPOs, and the innovation behind last year’s biotech series A raisers.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
NASDAQ’s first biotech public listings of 2024 provided hopeful signs for a rebound in the biotech IPO market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the performance of IPOs by CG Oncology and ArriVent and what’s next for the IPO market. They also discuss the growing IL-18 field, look ahead to the schizophrenia milestones coming this year, and size up the Singapore biotech ecosystem and what the country needs to do to cement a position on the global biotech map.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
Biotech investors are looking to catalysts that can create, or dramatically expand, commercial markets as they look ahead to a long-awaited recovery for industry. On the latest BioCentury This Week podcast, BioCentury’s editors assess the milestones on buysiders’ radar for 2024, including in areas such as obesity, pain and metabolic-associated steatohepatitis (MASH). They also discuss the influence of biopharma critic Arnold Ventures, a philanthropy that has reshaped the drug pricing public policy landscape; lung cancer data for Gilead's Trodelvy; and the week's expected biotech IPOs.
Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images
Investors and bankers are as upbeat about biotech’s prospects heading into 2024 as they have been since 2020, but maintaining the momentum that began building in 4Q23 is contingent on the Fed meeting expectations that it will ease interest rates. On the latest BioCentury This Week podcast, BioCentury’s editors assess the environment for financings and M&A in the year ahead. They also discuss Janet Woodcock’s legacy at FDA as she readies to step down at the end of the month and the latest developments in the abortion drug case.
Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images
Cautious optimism was the theme during a J.P. Morgan Healthcare Conference week that featured patchy skies, large-but-not-mega deals and a surfeit of sideline summits around San Francisco’s Union Square. BioCentury’s editorial team discusses the week’s M&A deals, including J&J's $2 billion takeout of ADC company Ambrx, and Merck & Co. acquiring T cell engager biotech Harpoon for nearly $700 million; takeaways from the Sachs Neuroscience Innovation Forum and other adjacent forums; and investor sentiment heading into the New Year.
Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images
A flurry of large acquisitions to close out 2023 is likely to carry into the New Year as pharmas continue to show appetite for late-stage assets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest trends in biotech M&A, potential takeout targets for 2024 and the impact on dealmaking of a more aggressive FTC. They also assess sentiment heading into next week’s J.P. Morgan Healthcare Conference, analyze future drivers of innovation in biotech, and preview the year ahead in regulation and public policy.
Music for the 24th Bio€quity Europe teaser produced by:
Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images
Signals from the Fed that rate cuts are on the way rallied biotech indexes last week, but is the uptick more than a blip? On the latest BioCentury This Week podcast, BioCentury’s editors discuss how interest rate cuts could spur a risk-on rotation back into the sector by generalist investors, the possibility of biotech outperformance in 2024, and what it will take for the IPO window to open. They also assess progress demonstrated by companies’ with next-generation gene editors at this year’s American Society of Hematology (ASH) meeting, as well as BioCentury’s analysis of new targets at the conference. The editors also offer their picks for the highlights (and lowlights) of 2023 and predictions for what’s in store in the New Year.
FDA’s decision to approve two gene therapies for sickle cell diseases could be transformative for patients, but both multimillion-dollar drugs will face access issues. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the companies, and for patients, following the approvals. The editors also analyze how AbbVie is restocking its pipeline via M&A, including its second multibillion deal in a week, a takeout of Cerevel, and why the acquisition is important beyond the pharma’s own portfolio. And Washington Editor Steve Usdin assesses BIO’s decision to name John Crowley as its new CEO and why the Biden administration’s new march-in policy is likely to affect very few drugs.
Biopharma’s latest pair of multibillion-dollar takeouts come in two of industry’s hottest areas: ADCs and obesity. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the move by Roche into obesity via its acquisition of Carmot Therapeutics and the winding journey of ADC company ImmunoGen to its $10.1 billion buyout by AbbVie. BioCentury’s editors discuss what FDA’s statement on the risk of T cell malignancy following BCMA- or CD19-directed CAR T cell therapy means for companies operating in the space.
Radiopharmaceuticals have experienced a resurgence over the past decade, with a series of approvals, billion-dollar deals and growing sales. On the latest BioCentury This Week podcast, Director of Biopharma Intelligence Karen Tkach Tuzman previews her upcoming analysis of the space, discussing the multidimensional nature of the technology’s evolution, and the field’s next-wave targets behind PSMA and SSTR2. BioCentury’s editors also discuss the legacies of two U.S. lawmakers who won’t stand for re-election, Reps. Anna Eshoo (D-Calif.) and Michael Burgess (R-Texas); the latest move by BioNTech to grow its global footprint; and the November rise in the XBI.
The world’s first approval of a CRISPR-based gene editing therapy, granted by the U.K.’s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also discuss the unintended consequences of the Inflation Reduction Act (IRA) on the development of orphan drugs and new legislation that aims to address the problem by providing an exemption to price negotiations for therapies that are approved only for orphan indications, regardless of how many. The team also reflects on the legacy of FDA’s Janet Woodcock ahead of her planned retirement next year; the sentiment coming out of last week’s Jefferies Healthcare Conference in London; and the aftermarket performance of two market debuts last week from antibody-drug conjugate CMO WuXi XDC Cayman and Mural Oncology.
Verve achieved the first proof of concept for an in vivo base editing therapy, but investor concerns weighed on the company’s stock, clouding the readout’s reception. On the latest BioCentury This Week podcast, BioCentury’s editors dissect the data for VERVE-101 in heterozygous familial hypercholesterolemia and discuss how the choice of initial target and indication for a new modality or technology can have a major impact on how POC data are perceived by investors. The editors also assess the latest developments related to the Inflation Reduction Act and assess a selection of biopharma deals and IPOs.
The controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could have for patients and future therapies that are submitted to the agency with less than clear-cut positive data. The editors also discuss innovations around new endpoints and technologies for clinical trials and the tepid reception for the latest biotech IPO, the debut by Lexeo.
The European Society for Medical Oncology (ESMO) had everything from practice changing Phase III data readouts to new solid tumor targets. On the latest BioCentury This Week podcast, BioCentury’s editors recap the biggest data presentations from last week’s annual ESMO meeting, including the impact of Phase III data for ADCs and bispecifics on the treatment landscape for tumors such as urothelial cancer and EGFR-mutant non-small cell lung cancer (NSCLC). The editors also discussed takeaways from the most recent progress in the confirmation of Monica Bertagnolli as director of the National Institutes of Health (NIH), and the latest step CMS has taken in implementing the Inflation Reduction Act (IRA). They also discussed Abingworth’s new $356 million co-investment fund, which, coupled with its 2021 vintage co-development fund, brings the VC firm’s firepower for investing in late-stage development programs to nearly $1 billion.
Daiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi’s pipeline strategy.
The editors break down Monday’s $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A space; and offer highlights from BioCentury’s deep dive into how academics and biotechs are expanding the therapeutic potential of base editors.
BayHelix’s Guo-Liang Yu and McKinsey’s Josie Zhou join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector during a preview of the BioCentury-BayHelix China Healthcare Summit. The summit kicks off at a time of record cross-border deals and validating comments from the leaders of MNCs such as Pfizer, Novartis and Sanofi that innovation by China biopharmas is world class. The 10th annual BioCentury-BayHelix China Healthcare Summit is Nov. 2-3 in Shanghai. Digital passes are also available.
Now that Vas Narasimhan has finished the major dismantling of Novartis, he’s turning his attention to fixing R&D. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the Swiss pharma now that Narasimhan has focused it down to what he calls a pure play innovative medicines company.
The editors also analyze the European Parliament’s proposed changes to the first major overhaul of European pharmaceutical law in 20 years, including suggested adjustments related to data exclusivity, orphan drugs and antimicrobials.
They also discuss what Novo Nordisk gains via a deal with Singapore’s KBP BioSciences and how the Inflation Reduction Act has prompted Relay Therapeutics to delay development of lirafugratinib (RLY-4008) to treat cholangiocarcinoma in favor of a larger indication
BMS’s acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week.
BioCentury’s editors also discuss their 4Q23 Public Markets Preview, including how private biopharma companies looking to go public in the next 12 months should be managing their path to that transition. Following last week’s analysis of the companies leading the transition of CAR T therapies into the autoimmune space, BioCentury’s editors also touch on the targets and technologies coming up behind the leading programs that could expand use of CAR Ts to a wider set of autoimmune indications.
They also discuss takeaways from ICER’s report on how CMS might approach drug price negotiation under the Inflation Reduction Act.
Biopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications.
BioCentury’s editors also discuss takeaways from BioCentury’s recent conversation with Sanofi CEO Paul Hudson; the latest developments for the Inflation Reduction Act; and notable biotech financings, including a $300 million private placement for Structure Therapeutics.
BayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the growth of cross-border dealmaking, and panel topics and speakers at the East-West Summit, which takes place Oct. 2-4 in Kendall Square.
That a broad swath of new money flowed into last week’s IPOs by RayzeBio and Neumora is a good sign for biotech and a departure from deals done last year, BioCentury's Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues assess the offerings and the companies’ aftermarket performance alongside NASDAQ’s six other top biotech IPOs of the year for signs of what’s next for companies looking to go public.
BioCentury’s editors also discuss what new regulatory requirements in China mean for Chinese biotechs hoping to debut on a stock exchange in the near future, as well as the latest developments in lawsuits related to the Inflation Reduction Act and an upcoming hearing on the IRA in the House.
Constructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development.
BioCentury’s editors also assess why the FTC made a deal with Amgen that will allow the company’s $27.8 billion acquisition of Horizon Therapeutics to proceed, and how an agreement by Regeneron on international pricing of a COVID-19 mAb could clear the path to confirmation of Monica Bertagnolli as the next NIH director.
What are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies.
Circular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit in Cambridge, Mass., and the Nov. 2-3 China Healthcare Summit in Shanghai.
There’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies.
BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the Scleroderma Research Foundation’s plans to bring the platform trial model to scleroderma.
A complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the dozens of companies that raised crossover cash before markets turned sour, as well as the digital transformation under way at Sanofi, which aims to use AI and data science to drive everything from candidate discovery to clinical trial planning, manufacturing optimization and supply chain management.
An analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentech Inc. CEO Alexander Hardy, and his perspective on how the Inflation Reduction Act (IRA) may impact future decision-making on drug development for small molecules. They also discuss takeaways from a Q&A with Leerink Partners’ Jeffrey Leerink and Dan Dubin, what’s next in BIO’s hunt for a permanent CEO, and the case of Stealth BioTherapeutics Corp. and whether the company’s regulatory experience raises questions about if FDA should improve the consistency with which it applies regulatory flexibility.
A hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest developments in industry litigation against the IRA and new FTC guidelines on antitrust rules.
With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview.
They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve.
Full approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable.
BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevidys delandistrogene moxeparvovec, the gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy that Usdin argued in an Editor’s Commentary shows flaws in evidence generation and regulatory processes.
FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple.
Emer Cooke may have already cemented her legacy as executive director of EMA through her leadership of the European regulator during the COVID-19 crisis. But she still faces a big task in navigating the agency through Europe’s new pharma legislation, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast.
Usdin and colleagues discuss a wide-ranging fireside chat held last week in Amsterdam with Cooke, including how the agency adapted post-Brexit and the differences that need to be appreciated between the European and U.S. regulators.
BioCentury’s editors also discuss the future of induced pluripotent stem cells (iPSCs) in cell therapies, a conversation with Forbion’s Wouter Joustra, a management buyout of SVB Securities, and why Senate Democrats are holding back on confirming a new NIH director.
A lawsuit over the Inflation Reduction Act by Merck & Co. suit signals to Republicans that the pharma has no compunctions about attacking Democrats, the Biden administration and the president himself, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleague discussed the significance of the move by Merck, its likelihood of success and why the pharma chose its combative tone for the first lawsuit challenging the Medicare drug price-setting provisions of the IRA.
BioCentury’s editors also assessed remarks at the BIO convention by FDA Commissioner Rob Califf related to the accelerated approval pathway, takeaways from Friday’s FDA panel on Alzheimer’s drug Leqembi and data presented at the American Society of Clinical Oncology annual meeting for multicancer early detection tests. This week’s podcast is sponsored by Cancer Research Horizons.
ASCO’s kickoff included blunt comments from two CEOs who said the IRA is causing their companies to delay launches of cancer drugs for smaller indications, BioCentury Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discussed remarks at the American Society of Clinical Oncology conference by Novartis' Vasant Narasimhan and Genentech's Alexander Hardy regarding how the Inflation Reduction Act is forcing the companies to make difficult decisions regarding their pipelines and patients’ access to their therapies.
The podcast team also assessed highlights from ASCO’s data presentations, including antibody-drug conjugate readouts from partners AstraZeneca and Daiichi Sankyo, and Kelun Pharmaceutical and Merck & Co., as well as the emergence of Alkeus, which has attracted $150 million in series B money for its Stargardt program and Joshua Boger to its executive chairman position. This week’s podcast is sponsored by Cancer Research Horizons.
Two Phase I checkpoint inhibitor readouts due at ASCO 2023 are bringing excitement back to immuno-oncology, said BioCentury’s Lauren Martz on the latest BioCentury This Week podcast. Martz and her editorial team colleagues discuss what stands out about the data for LAG3 inhibitor fianlimab from Regeneron and anti-TIGIT mAb tiragolumab from Genentech.
The editors also break down takeaways from BioCentury's conversation on precision neuropsychiatry with Husseini Manji, co-chair of the U.K. Mental Health Mission, and assess BIO’s call for CMS to provide more clarity about its plans for implementing provisions in the Inflation Reduction Act that give some small biotechs a temporary exemption from Medicare drug price negotiation. This week’s podcast is sponsored by Cancer Research Horizons.
If FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec.
Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bertagnolli to prioritize at NIH; and what the debt ceiling means for the life sciences. And on the heels of Bio€quity Europe, Editor in Chief Simone Fishburn delivers her insights from BioCentury’s European conference.
This week’s podcast is sponsored by Cancer Research Horizons.
As biotechs continue to find their footing in the new normal of capital scarcity, the industry is beginning to see “green shoots” in M&A activity and preclinical deals, Ysios Capital’s Guillem Laporta said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. In conversation with BioCentury and Gilde Healthcare’s Joep Muijrers, Laporta described a fundraising environment where disruptive, innovative companies are continuing to get funded. The group also discussed Gilde’s plans for deploying its recent record VC fund, Ysios portfolio company Mineralys’ successful NASDAQ IPO and next year’s Bio€quity Europe conference, scheduled for May 2024 in San Sebastián, Spain.
For many private European biotechs, flat or down valuations have become the new normal as they struggle to raise money despite having quality science, +ND Capital’s Dani Bach said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. Investors, he said, are flocking to a handful of outsize fundraising rounds out of fear. In conversation Monday with Jeff Cranmer and Stephen Hansen of BioCentury and Poolbeg’s Jeremy Skillington, Bach described a bipolar fundraising environment in which the “bulk of companies are struggling for money and a few are getting massive amounts of money even beyond their wild expectations.” Bach, Skillington and BioCentury's editors also discuss Ireland's burgeoning biotech ecosystem, Europe's biopharma hubs and the performance of U.K.'s biotechs listed on the London Stock Exchange. This episode is sponsored by Jeito Capital.
This year’s Bio€quity Europe conference aims to define what European biotech’s “playbook for success” should be in the industry’s “new normal,” BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the twenty-third incarnation of the May 14-16 meeting in Dublin. Seroba Life Sciences’ Alan O'Connell and Avectas' Mary Martin joined Flores and BioCentury Editor-in-Chief Simone Fishburn to outline the opportunities and challenges faced by Ireland’s biopharma ecosystem and preview some of the conference’s events and panel discussions, and EBD's Tina Elder detailed what to expect in terms of attendees at the event.
Acelyrin last week parlayed a late-stage asset for hidradenitis suppurativa and veteran leadership into one of biotech’s largest-ever NASDAQ IPOs. On the latest BioCentury This Week podcast, BioCentury’s editors discussed how Acelyrin generated outsized demand for its offering and assessed Alzheimer’s data for Eli Lilly's donanemab, the promise and challenges of digital endpoints and takeaways from the latest BioCentury Show, which featured incoming FogPharma CEO Mathai Mammen in conversation with Editor in Chief Simone Fishburn. This week’s podcast is sponsored by Cancer Research Horizons.
Biopharma companies believe a draft law that seeks to overhaul European pharmaceutical policy for the first time in years is out of sync with innovation, Washington Editor Steve Usdin said on the latest BioCentury This Week. Usdin and colleagues assessed the EC’s proposals in the legislation, as well as what’s changed since a version of the draft was leaked earlier this year. BioCentury’s editors also discussed the implications of FDA’s acceptance of NfL as a surrogate endpoint for amyotrophic lateral sclerosis for companies with clinical neurodegeneration programs, plus the $5.9 billion takeout of geographic atrophy company Iveric bio by Astellas, and a deal by Sanofi to license rights to a Pompe therapy from Maze Therapeutics.
Top-tier European VCs are still attracting capital to deploy, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast, with LPs looking at funds’ track record and the track record for biotech. Hansen discusses how Forbion and Gilde will deploy their newly announced funds as well as what’s new in their strategies as they raise some of the biggest VC vehicles ever in Europe. BioCentury’s editors also discuss the U.S. Supreme Court’s mifepristone ruling and comments filed by the biopharma industry about CMS’s draft guidance on implementing the Inflation Reduction Act.
BioCentury’s analysis of AACR 2023 abstracts found new targets light on immuno-oncology, said Executive Director Lauren Martz on a special edition of the BioCentury This Week podcast. Martz and colleagues debated whether the findings suggest immuno-oncology is losing its luster, and assessed abstracts on next-generation PRMT5 inhibitors and first-in-human studies, as well as the latest data from Merck & Co. and Moderna on their neoantigen vaccine in melanoma.
M&A such as Monday’s proposed takeout of Prometheus by Merck & Co. is one of the few factors that can help reverse the negative sentiment hanging over biotech, Director of Biopharma Intelligence Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues discuss Monday’s deal in the context of the prolonged market downturn as they assess the takeaways from BioCentury’s 2Q23 Financial Markets Preview. BioCentury’s editors also discuss the implications for FDA of court rulings on abortion drug mifepristone and how Gilead is building its oncology franchise.
The ruling on abortion drug mifepristone issued Friday by Texas District Judge Matthew Kacsmaryk could destabilize drug regulation, opening up every FDA approval to second guessing by any court in the U.S., Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin assesses the implications of the decision and sheds light on the thinking of former senior FDA attorneys regarding the case. BioCentury’s editors also discuss the latest from venture firms Canaan, SR One, and newly launched Cure Ventures, and deliver takeaways from BioCentury’s recent webinar on the Inflation Reduction Act, “Navigating the IRA.”
On the latest BioCentury This Week podcast, BioCentury’s editors assess the implications of the FTC’s challenge to the $7.1 billion acquisition of cancer screening company Grail by next-generation sequencing company Illumina. They also discuss what’s at stake as the U.S. Supreme Court weighs arguments in the patent dispute over anti-PCSK9 mAbs between Sanofi and Amgen, and how CEOs of gene therapy companies are thinking about the competitive landscape at a time when products with preliminary evidence of safety and efficacy are dropping out of clinical development across multiple indications. This week’s podcast is sponsored by Jeito Capital.
On the latest BioCentury This Week podcast, BioCentury’s editors assess responses to their VC survey regarding the collapse of Silicon Valley Bank in light of First Citizens’ acquisition of SVB. BioCentury’s editors also discuss how FDA’s advisory committee meeting for tofersen from Biogen and Ionis bolsters the case for neurofilament as a surrogate endpoint in amyotrophic lateral sclerosis, and why last week’s FDA draft guidance on accelerated approval could make cancer drug development harder for small biotechs. This week’s podcast is sponsored by Jeito Capital.
On the latest BioCentury This Week podcast, BioCentury’s editors assess how companies are upending pipeline and business strategies due to the Inflation Reduction Act, along with other takeaways from a survey on the IRA’s implications, conducted by BioCentury with the support of BIO. They also discuss CMS’s memo outlining how it intends to implement the IRA’s price-setting provisions, the T cell therapy landscape and insights from BioCentury’s Distillery. This week’s podcast is sponsored by Jeito Capital.
On a special edition of the BioCentury This Week podcast, Editor in Chief Simone Fishburn and Director of Biopharma Intelligence Stephen Hansen assess the priorities for VCs and their portfolio companies in the immediate aftermath of the collapse of Silicon Valley Bank. They also discuss the gap left in the biotech ecosystem given SVB’s unique relationship with VCs and small companies, and what the knock-on effects may be on the sector as it continues to grapple with the bear market.
On the latest BioCentury This Week podcast, BioCentury’s editors assess the fallout from the collapse of SVB and the sale of SVB UK to HSBC. BioCentury’s editors also discuss the proposed $43 billion acquisition of Seagen by Pfizer, takeaways from CDER Director Patrizia Cavazzoni’s conversation with Washington Editor Steve Usdin on The BioCentury Show and Editor in Chief Simone Fishburn’s call for pharma to put more women in the C-suite. This week’s podcast is sponsored by Jeito Capital.
On the latest episode of the BioCentury This Week podcast, BioCentury’s editors assess the challenges and opportunities facing Christopher Viehbacher as he begins to implement his vision for Biogen. The team also analyzes the state of play among NK cell therapy companies and discusses highlights from BioCentury’s Emerging Company Profile of Paratus Sciences Corp., a well-funded biotech being built around the idea that insights derived from the study of bat biology can be applied directly to human health and health security. This week’s podcast is sponsored by Jeito Capital.
Leaked drafts of legislation overhauling Europe’s pharmaceutical laws are causing consternation at biopharma companies. BioCentury’s editors discuss how the revised framework could cut IP protections and why any benefits from the legislation are not sufficient to attract investment to Europe. They also discuss the potential implications of an imminent ruling in a Texas lawsuit challenging FDA’s approval of abortion drug mifepristone, and comment on the departure of FDA’s Billy Dunn.
On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the latest payment models from CMS could mean for cell and gene therapies, and how a new model could incentivize the completion of confirmatory trials for drugs with accelerated approval. BioCentury's editors also discuss the outlook for China's public markets and details around the genetic medicine delivery technology of recently launched Aera Therapeutics.
Last week’s Oncologic Drugs Advisory Committee meeting to discuss PD-1 inhibitor Jemperli offered insights into new endpoints, single-arm studies and the future of FDA advisory committee panels. On the latest BioCentury This Week podcast, BioCentury’s editors assess how GSK's standout dataset in a rare form of rectal cancer could qualify the program for exceptions to FDA’s standard practices and what it could mean for patients. BioCentury’s editors also discuss signs of greater regulatory flexibility on the important but controversial overall survival endpoint, highlights from BioCentury’s Distillery and what NASDAQ debuts by Mineralys and Structure say about the state of the market for biotech IPOs.
Via new guidance and its Project Optimus, FDA is pushing companies to do dose-optimization studies instead of maximum-tolerated dose studies, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the burdens and benefits of the shift, in particular for biotechs. BioCentury’s editors also assess new challenges and opportunities for FDA and regulated industry now that the agency is starting to implement PDUFA VII and mandates from the spending bill passed by Congress late last year, including clinical trials diversity, and analyze a move in the House of Representatives to ban the use by federal or state governments of quality-adjusted life years (QALYs) to make health coverage or pricing decisions.
BIO’s push for FDA to be more flexible on accelerated approval requirements is unlikely to resonate at the agency, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why BIO is concerned about the “erosion” of accelerated approval as FDA considers whether requiring confirmatory trials to be under way at the time of approval should be the default policy. He then details the trade group’s other top priorities. Also on the podcast: how imminent climate disclosure rules from the SEC could affect biotechs and recent trends in venture financing.
New manufacturing systems for CAR Ts aren’t just about speed, Executive Director for Biopharma Intelligence Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues discuss the safety, efficacy and access benefits from rapid manufacturing platforms, and how these systems are set to change the way CAR T cells are delivered to patients. BioCentury’s editors also analyze the state of incentives for orphan drug development as the Orphan Drug Act turns 40, how the FTC’s non-compete proposal could have unanticipated effects for biotech, and what solutions former FDA commissioners are proposing to battle misinformation about science.
Investors broadly agree that biotech indexes won’t revisit the lows seen last year, but they’ll need their portfolio companies to survive until the industry begins its comeback, said Director of Biopharma Intelligence Stephen Hansen on the latest BioCentury This Week podcast. Discussing key takeaways from BioCentury’s 2023 Financial Markets Preview, Hansen detailed reasons to be positive in the year ahead, but cautioned that the financing windows will continue to be narrow and companies without a material catalyst this year need to deploy all the tools at their disposal to stay alive. Hansen and colleagues also discussed the milestones buysiders expect to drive excitement this year, and the outlook for M&A and partnerships, including the impact of the Inflation Reduction Act on dealmaking.
A trio of billion dollar deals for late-stage and commercial assets featuring contingent value rights were among the highlights of the first day of the J.P. Morgan Healthcare Conference in San Francisco on Monday. BioCentury's editors discuss AstraZeneca's takeout of CinCor, Ipsen's buy of Albireo and Chiesi's acquisition of Amryt as well as other takeaways from JPM, the CERSI summit and the Neuroscience Innovation Forum. The team also discusses the latest in Alzheimer's.
The U.K. government is signaling that life sciences companies will be shielded from changes to an R&D tax relief policy that would otherwise leave small biotechs losing millions of pounds, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss the behind-the-scenes initiative by the U.K. BioIndustry Association to protect companies from being affected by serious unintended consequences of the policy changes as they continue to weather the bear market.
BioCentury’s editors also assess documents released by Congress that shed light on Biogen's rationale for how it priced Alzheimer’s drug Aduhelm, trends in FDA’s 2022 approvals and what the editorial team is looking for in the year ahead.
Phase III results for resmetirom from Madrigal Pharmaceuticals are more than enough for a regulatory submission in non-alcoholic steatohepatitis, said BioCentury Director of Biopharma Intelligence Paul Bonanos. Bonanos and colleagues discuss what Madrigal got right in running its trial for the challenging NASH indication, and what’s next in the pipeline. BioCentury’s editors also assess highly anticipated, heavily scrutinized data from Moderna among other 4Q22 readouts from neoantigen programs, as well as translational highlights from BioCentury’s Distillery.
A strategy for navigating the Inflation Reduction Act is essential for every biopharma company, regardless of size or location, Washington Editor Steve Usdin said on a special edition of the BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss why creating an IRA strategy is so complex, when and how CMS is going to set prices for drugs selected for scrutiny and what the chances are that the act can be repealed or modified.
The $28.7 billion takeout of Horizon Therapeutics by Amgen marks a continuation of the large cap biopharma’s return to the inflammatory and autoimmune space where it’s been most commercially successful, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and his BioCentury colleagues discuss the deal’s synergies as well as new targets and IL-18 data at the American Society of Hematology (ASH) conference, and the evolving landscape for selective estrogen receptor degraders.
CTAD data for lecanemab showed more definitively than any past readout that targeting β-amyloid can lead to clinical benefit for Alzheimer’s patients, but the field is still wrestling with its use as a surrogate endpoint, BioCentury Executive Editor Selina Koch said on the latest BioCentury This Week podcast. Koch and the BioCentury podcast team break down the implications of data from Eisai and Roche at last week’s Clinical Trials on Alzheimer’s Disease meeting and look ahead to what’s next for the field. BioCentury’s editors also discussed how proposed changes to the U.K.’s R&D tax credit scheme could hurt British biotechs and what regulatory heads of global biopharmas who are members of the Charles Forum are envisioning for the post-COVID regulatory environment.
A model term sheet created by a consortium of academic institutions, VCs and law firms could reduce the negotiation time around life sciences start-ups for universities and VCs by 80%, Associate Editor Stephen Hansen said on the latest BioCentury This Week podcast. Hansen detailed how the consortium came together and what it hopes to accomplish. The BioCentury editors also discussed implications of CSL's decision to price the first hemophilia B gene therapy approved by FDA at $3.5 million, as well as an FDA-NCI study that could serve as prototype for streamlined pragmatic trials.
There are clear indicators of the maturation of China’s biotech sector, although east and west biopharma leaders have diverging views on how easy cross-border investment will be going forward, BioCentury’s Editor-in-Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn detailed her takeaways from the summit held last week, while Executive Editor Selina Koch reviewed her panel on the optimism R&D leaders have for the future role multi-omics can play in drug development. BioCentury editors also discussed the recent appointments of Chris Viehbacher as CEO of Biogen and David Epstein of Seagen and the challenges each face at their respective embattled biotechs.
As China’s biopharma companies experience their first “biotech winter,” they should be engaged in active portfolio management, stopping projects that will not meet their investors’ expectations, Agio Capital General Manager Henk Joos said on BioCentury This Week. On a special East-West Summit edition of the podcast, Joos and Immune-Onc Therapeutics founder and CEO Charlene Liao discussed pipeline prioritization and other company survival tactics during today’s difficult financing environment.
Cash conversation and sticking to priorities are essential for China’s biotech’s as they navigate today’s gloomy funding environment, Zhaoke Ophthalmology’s Lisa Feng said on a special East-West Summit edition of the BioCentury This Week podcast. Feng, who is CBO and CFO of Zhaoke, Jones Day’s Tony Chen and Paul Hastings’ Phoebe Yan discuss challenges of compliance risk in a digital world, China’s value-based procurement and IP landscape and the environment for IPOs and licensing deals for China’s biotechs.
The lack of a “red wave” in the U.S. midterm elections sets up a “last gasp of old-fashioned, horse-trading politics” by lawmakers that could affect multiple pieces of life sciences legislation, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin details what’s at stake for biopharma in Washington during the remaining weeks of 2022, and what’s in store for life sciences in the next session of Congress. BioCentury’s editors also discuss trends at this year’s Society for Immunotherapy of Cancer (SITC) conference and the latest from the Distillery, BioCentury’s summaries of top translational papers highlighting new targets and technologies with disease-modifying effects.
BIO needs to pick a leadership team rather than a leader to give the trade group all the skills it needs moving forward, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and Editor in Chief Simone Fishburn discuss how BIO needs to address the challenges it now faces, as well as the results of BioCentury’s industry-wide survey on the state of the trade group.
BioCentury’s podcast team also assess the latest developments in RSV product development, the infectious disease pipelines of Pfizer and GlaxoSmithKline, and top takeaways from Fishburn’s conversation on The BioCentury Show with Andy Plump, who is president of R&D at Takeda
Biopharmas and investors have been warning of the Inflation Reduction Act’s potential to hurt patients — concerns that had been theoretical until last week, when Alnylam became the first company to announce that it may abandon plans to add an indication to an orphan drug’s label. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a provision in the IRA prompted the biotech to pause plans to start a Phase III trial of vutrisiran for Stargardt disease, what other therapies might be affected and the impact on patients. The BioCentury podcast team also discusses how Argenx is applying lessons of past orphan drugs to the launch of myasthenia gravis drug Vyvgart, as well as non-profit Accumulus Synergy Inc.’s plans to bring interactions between drug sponsors and regulators, and among regulators, into the 21st century.
McKinsey’s Franck Le Deu and BayHelix’s Guo-Liang Yu join the BioCentury This Week podcast to discuss globalization and cross-border innovation in the biopharma and preview the upcoming BioCentury-BayHelix East-West Summit. BioCentury’s co-founders — CEO Dave Flores, Chairman Karen Bernstein — and Editor in Chief Simone Fishburn and BioCentury head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the current environment for cross-border dealmaking and expected highlights of the East-West Summit, which will take place in Redwood City, Calif., Nov. 14-16.
A pair of neurology companies are in the spotlight on the latest edition of the BioCentury This Week podcast. BioCentury’s editors assess how Lundbeck has evolved in the past five years, with a fresh emphasis on first in class in its revamped pipeline, and how Biogen could acquire its way into being a near-term growth company. BioCentury’s editors also discuss the Biden administration’s initiative that seeks to compensate for decades of underinvestment in the nation’s biomanufacturing capacity and takeaways from Nora Volkow, director of NIH’s National Institute on Drug Abuse, during her appearance last week on The BioCentury Show.
On the latest BioCentury This Week podcast, Senior Editor Karen Tkach Tuzman surveys the landscape of neoantigen cancer vaccines, touching on what’s changed in the past five years, 2022’s key readouts and what’s next for the field. Washington Editor Steve Usdin discusses the White House’s plans to use executive powers to reduce drug prices and, recapping his latest Editor’s Commentary, explains why he believes the U.S. and China should not allow rivalry in life sciences to turn into enmity that hurts patients. Finally, Editor in Chief Simone Fishburn assesses what turmoil in the U.K. means for the country’s burgeoning life sciences sector.
On the latest BioCentury This Week podcast, Washington Editor Steve Usdin details the circumstances leading up to Michelle McMurry-Heath’s resignation as CEO of BIO on Monday. The podcast team also discuss BioCentury’s 4Q22 Financial Markets Preview, with Associate Editor Stephen Hansen assessing biotech’s attempt to emerge from the ongoing bear market recovery as inflation and rising interest rates foster a risk-off environment. Senior Editor Karen Tkach Tuzman discusses the latest translational tidbits from BioCentury’s Distillery and the impact Nobel Prize laureate Carolyn Bertozzi has had on the biotech industry.
The neurodegeneration field had two big wins with even bigger implications for the future of Alzheimer’s disease and ALSs, Executive Editor Selina Koch says on the latest episode of BioCentury This Week. Koch lays out the importance of the positive Phase III data for lecanemab in Alzheimer’s and the coming debate over access to the therapy, while also noting the potential for read-through to other neurodegenerative diseases from FDA’s approval of Amylyx's ALS drug Relyvrio. BioCentury’s editorial team also discusses mounting pressure on the Biden administration to curb outbound investments from the U.S. into China and the work of biopharma non-profit Life Science Cares.
Everything’s at stake for FDA as user fee legislation approaches a critical deadline this week, Washington Editor Steve Usdin says on the latest episode of BioCentury This Week. Usdin details the next steps in the process, which FDA reforms are being dropped from the “clean” user fee bill and the future of healthcare legislation. BioCentury’s editorial team also recaps the top takeaways from Global Blood Therapeutics CEO Ted Love’s appearance on The BioCentury Show, previews the upcoming BioCentury-BayHelix East-West Biopharma Summit and assesses two upcoming milestones for Biogen: an FDA decision on tofersen for amyotrophic lateral sclerosis and Phase III data for Alzheimer’s therapy lecanemab that’s due from partner Eisai.
A year after it reported its first clinical data showing CRISPR-based gene editing may live up to its promise, Intellia has provided evidence for the second time that its platform can knock down a clinically relevant target in the liver, and revealed the first data showing it can deliver clinical benefit. On the latest BioCentury This Week podcast, BioCentury's editors discuss the hereditary angioedema data for NTLA-2002. They also explain why the Inflation Reduction Act could have an outsized effect on the development of orphan drugs and how an Executive Order related to the Committee on Foreign Investment in the United States (CFIUS) signed by President Joe Biden singles out biotech and biomanufacturing for intensified foreign investment scrutiny.
Biopharma executives and investors are bracing for the impact of the newly passed Inflation Reduction Act. On the latest BioCentury This Week podcast, BioCentury's editors discuss pharma CEOs’ warnings that the law will reduce incentives for small molecule drug development, how biotech VCs may adjust deployment of their funds and how the government could implement the law.Turning to readouts from the European Society of Medical Oncology Congress, the BioCentury podcast team explains why the latest data for Amgen's Lumakras could shake up the KRAS inhibitor race and how Chinese investigator-initiated trials are accelerating CAR T innovation.
Digital fluency, the imperative to have an impact on society and an eagerness to make change now, not in future decades, mark the future leaders of the industry, says BioCentury Editor in Chief Simone Fishburn. On the fifth and concluding BioCentury This Week podcast accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the defining traits of industry’s incoming generation of leaders and the evolving skills required for the future of biotech. Access all of BioCentury's Back to School content here.
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The need to recruit and train regulators is acute in developed as well as low- and middle-income countries, BioCentury Washington Editor Steve Usdin says. On the fourth of five BioCentury This Week podcasts accompanying Back to School 2022, Usdin and BioCentury’s editorial team discuss how drawing top talent means agencies must persuade candidates that careers are infused with purpose and support a vital mission. BioCentury Senior Editor Karen Tkach Tuzman says biopharma companies, facing their own talent crunch, will benefit from making themselves more visible, accessible and instructive to new entrants. Access all of BioCentury's Back to School content here.
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Solving the biopharma industry’s management crunch will require today’s leaders to open their networks, and provide more leadership opportunities and mentoring to rising leaders, says BioCentury Editor in Chief Simone Fishburn. On the third of five BioCentury This Week podcasts accompanying Back to School 2022, Fishburn and BioCentury’s editorial team discuss the group of employees who see the C-suite as their next step, why they want to get there and the impediments they must overcome. BioCentury’s editors also assess how VCs are building boards to guide first-time CEOs, and discuss concerns that the increase in compensation across the biopharma sector has gotten out of hand. Access all of BioCentury's Back to School content here.
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The past two years have forced a reckoning for CEOs throughout the biopharma industry that will shape the next generation of success stories. On the second of five BioCentury This Week podcasts accompanying Back to School 2022, BioCentury’s podcast team discusses what makes a good CEO and how leaders are building teams to manage successful biotechs. BioCentury’s editors also draw on the results from BioCentury’s Talent Survey to discuss the flourishing cohort of women CEOs leading today’s biopharmas and how industry is thinking about diversity, equity and inclusion.
BioCentury’s 30th annual Back to School edition focuses on talent: where to find talent and how to nurture it. It’s a special Back to School package because the issue involves every person in the life sciences ecosystem at a critical time in the biopharma industry’s evolution, says Editor in Chief Simone Fishburn on the latest BioCentury This Week podcast. Fishburn and the BioCentury podcast team set the stage for the five-day Back to School series, which draws on analysis of BioCentury’s Talent Survey and interviews with more than 85 people at all career stages. The series includes dives into C-suites, the flourishing cohort of women CEOs, industry’s rising leaders and heavy lifters, VCs, regulators and more.
Despite public market investors shying away from preclinical companies amid biotech’s bear market, large biopharmas have ramped up their deal making for early-stage assets and technologies and are willing to pay for access to new modalities, says BioCentury’s Stephen Hansen on the latest BioCentury This Week podcast. Hansen and colleagues also discuss the implications of FDA’s approval of gene therapy Zynteglo from bluebird bio Inc., and the latest advances and leaders in the field of epigenome editing.
A flurry of follow-on financings last week suggests a receptive market for companies with recent catalysts, BioCentury’s Paul Bonanos says on the latest BioCentury This Week podcast. Bonanos and colleagues discuss what last week’s offerings, led by schizophrenia company Karuna Therapeutics, say about which companies might be able to tap the public markets and under what circumstances. The podcast team also examines how computational protein design is shifting its center of gravity from mechanistic calculations based on physical forces to more powerful machine learning approaches trained on reams of data, and why a deal between the SEC and its Chinese counterpart on cross-border audits could be nearly in hand.
The proposed $5.4 billion takeout of sickle cell company Global Blood Therapeutics by Pfizer is the latest sign of life in biotech M&A, BioCentury Associate Editor Paul Bonanos says on the BioCentury This Week podcast. Bonanos and colleagues explain how Pfizer plans to use its global reach to get Oxbryta to parts of the globe most affected by sickle cell disease, which disproportionately affects people of African, Middle Eastern and South Asian descent. Plus: how schizophrenia data from Karuna makes the biotech ripe for a takeout; amyloidosis data from Alnylam; and why Amgen’s latest data for Lumakras suggest the future of one of the most promising KRAS inhibitor combinations is now in doubt.
Acquisition target Seagen has carved out such a differentiated portfolio of antibody-drug candidates that the company may not see much direct competition from other ADCs in the near term, BioCentury’s Lauren Martz says on the latest edition of the BioCentury This Week podcast. Martz and the BioCentury podcast team analyze how Seagen has built a pipeline around almost entirely first-in-class targets and assess how the latest cut of data for the company’s Padcev enfortumab vedotin-ejfv could broaden the ADC’s reach among cancer patients.
As Severin Schwan’s steady hand on the tiller of Roche passes to another insider, BioCentury’s podcast team examines how initiatives during the outgoing CEO’s tenure, including those related to digital and data science, handed a solid deck of cards to diagnostics head Thomas Schinecker as he takes on the top job at the Swiss pharma. Plus: Washington Editor Steve Usdin assesses Sen. Richard Burr’s attempt to deliver a “clean” user fee bill, pharma and biotech executives’ chances to revise the drug price regulation provisions of the Democrats’ budget reconciliation bill, and why it might be too late for President Joe Biden to get a nominee for NIH director through Congress.
Sen. Richard Burr’s new approach to a critical medical products user fee bill funding FDA must be taken seriously because the clock is ticking, and it’s ticking loudly, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin explains why Burr has introduced the bare-bones legislation and what’s at stake for industry in the weeks ahead. BioCentury's editors also discuss FDA’s neurodegeneration blueprint, clinical updates in ALS from Clene and base editing from Verve, and plans to reshape Novartis.
Even with signs that the biotech winter may be starting to thaw, buysiders continue to expect more near-term pain for the sector as consolidation continues for smaller companies with limited cash and few options for raising more, Associate Editor Stephen Hansen says on the latest edition of the BioCentury This Week podcast. Hansen sums up the takeaway messages from BioCentury's 3Q22 Financial Markets Preview, detailing the impact of the barren financing landscape, investors’ priorities, and whether the sector has finally hit bottom. The podcast team also discuss an initiative by gene therapy companies to resolve and pre-empt immune-related toxicities seen in some Duchenne muscular dystrophy trials and the latest push by Congressional Democrats and the Biden administration to regulate the prices of some drugs.
AstraZeneca’s takeout of single-asset spinout TeneoTwo for $100 million up front is but the latest payout to shareholders in TeneoBio, who could stand to see even more upside in the years ahead, says Associate Editor Paul Bonanos on the latest edition of the BioCentury This Week podcast. Bonanos and the BioCentury editors also discuss how TeneoTwo investor Lightspeed Venture Partners has deepened its commitment to life sciences investing; Arch Venture Partners’ plans to deploy its new $3 billion venture fund; and the latest translational highlights from BioCentury’s Distillery and Translational in Brief sections. Plus: A preview of BioCentury's fall conference.
On the latest BioCentury This Week podcast, a pair of deals demonstrates how Galapagos CEO Paul Stoffels is shifting the Belgian biotech’s strategic focus from small molecules toward a diversified portfolio. Plus: why Friday’s Supreme Court decision to overturn Roe v. Wade sets the stage for legal and legislative battles that could have broad implications for biopharma and how a new crop of Indian biotechs are seeking to offer dramatically cheaper CAR T therapies. This week’s podcast is sponsored by the BioCentury-BayHelix East-West Summit 2022.
On the latest BioCentury This Week podcast, Washington Editor Steve Usdin details how the Advanced Research Projects Agency for Health is taking shape as the new U.S. agency seeks to deliver transformative science and the latest moves by Rep. Anna Eshoo to change its structure via legislation. The podcast team also explores the U.K. NHS’s deal with Pfizer Inc. and Shionogi & Co. Ltd. on a subscription-based payment pilot for antibiotics, which could serve as an example for other payers considering similar initiatives; why an IP agreement by the WTO will do little to move the needle on COVID countermeasures; and top takeaways from Zai Lab CEO Samantha Du on The BioCentury Show. In addition, they call for members of the biopharma community to participate in a BioCentury survey on the talent crunch facing industry. All responses will remain confidential.
Stellar data for Vertex Pharmaceuticals and CRISPR Therapeutics could set a high bar for the next generation of gene editing players to beat in β thalassemia and sickle cell disease, indications that had previously been considered as the best disease to show proof-of-concept for the modality, said Executive Director of Biopharma Intelligence Lauren Martz on the latest edition of BioCentury This Week. The BioCentury podcast team also reviews Associate Editor Stephen Hansen’s analysis of how the trend of private equity firms acquiring or partnering life sciences VCs will impact the financing environment, and Washington Editor Steve Usdin’s take on the one big difference between the PDUFA user fee bills making their way through the House and Senate. Senior Editor and Head of Discovery & Preclinical Development Karen Tkach Tuzman also reviews the latest highlights from BioCentury’s Distillery
Stellar ASCO data for Enhertu show how there’s “massive ground” that can still be covered and improved upon by applying new modalities against older targets, said Editor in Chief Simone Fishburn on the latest edition of BioCentury This Week. Fishburn and the BioCentury podcast team dig into the data for antibody-drug conjugate Enhertu from AstraZeneca and partner Daiichi Sankyo for previously treated HR-positive, HER2-negative breast cancer patients. They also assess how new modalities are breathing fresh life into HER3 and explore the themes raised by Fishburn in her conversation with Richard Pazdur, and some of his FDA colleagues at the American Society of Clinical Oncology conference in Chicago. The team also discusses the latest cut of data for tofersen from Biogen in SOD1-mutant amyotrophic lateral sclerosis.
The latest data cut for KRAS G12C inhibitor adagrasib from Mirati Therapeutics underwhelmed investors. On the latest BioCentury This Week podcast, BioCentury’s editors discussed the readout, which came in an abstract ahead of this week’s American Society of Clinical Oncology meeting, and previewed some of ASCO’s most anticipated data, which will emerge in “late-breaker” presentations. The podcast team also explored the legal battle over IP related to CRISPR editing in bacterial cells, the latest on an investigation by CStone Pharmaceuticals into a derivative investment that broke company policy, the launch of the Advanced Research Project Agency for Health and the status of user fee negotiations in Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre. For more information visit, msd.com/licensing.
On the latest BioCentury This Week podcast, BioCentury’s editors explore how biotechs are turning to tumor targeting, IL-15 expression and alternate cell sourcing to enhance the potency and longevity of NK cell therapies. The podcast team also discusses Janet Woodcock’s new remit at FDA, Bristol Myers Squibb's pullout from Russia and the bipartisan effort moving medical product user fee reauthorization legislation forward in both houses of Congress. This week’s podcast is sponsored by MSD, whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre. For more information visit, msd.com/licensing.
Ensuring that a biotech reaches its key inflection points as effectively as possible during the ongoing capital crunch affects a company across the board, including its people, pipeline and financing toolkit, Shorla’s Sharon Cunningham said on a special Bio€quity Europe edition of the BioCentury This Week podcast. Cunningham and BII’s Bobby Soni joined the BioCentury podcast team to discuss navigating the downturn as a CEO of a private biotech, the untapped talent pools able to run start-ups and the ecosystem in Bio€quity Europe’s next site, Ireland. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.). For more information visit, msd.com/licensing.
Even as industry is facing a global talent crunch, Europe’s biotechs have it better than ever, Medicxi’s Francesco De Rubertis said on a special edition of the BioCentury This Week podcast recapping the first two days of the Bio€quity Europe conference in Milan. He and MSD’s Khatereh Ahmadi joined the BioCentury podcast team to discuss the battle for top talent and the state of deal-making amid the ongoing downturn. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre. For more information visit, msd.com/licensing.
The sale of a minority stake in Sofinnova Partners to PE firm Apollo will allow the European VC to grow while retaining its independence. Fresh off a conversation with Sofinnova’s Antoine Papiernik, Associate Editor Stephen Hansen explains the 50-year-old firm’s proactive approach to finding a partner among private equity firms and what’s next for the firm now that it has more financial firepower. The podcast team also discusses the latest translational tidbits from BioCentury’s Distillery, the first look at clinical data from the CRISPR-based gene editing platform of Caribou and how biopharmas are weighing their commitment to Russian patients against calls to disengage from the country. This week’s podcast is sponsored by MSD (Merck & Co. Inc. in the U.S.), whose London-based European Innovation Hub includes a business development and licensing team, clinical teams and its U.K. Discovery Research Centre. For more information visit, msd.com/licensing.
Industry’s dueling headwinds of capital and talent are the focus of this year’s Bio€quity Europe meeting, and in a special episode of BioCentury This Week, two veterans of the burgeoning Italian life sciences ecosystem, Sofinnova Partners' Graziano Seghezzi & Ambrosetti's Corrado Panzeri, say the country’s biotech sector now has the capital and networks to weather the storm.
The House Energy & Commerce Committee has a bipartisan deal on reauthorizing FDA user fees that sets the parameters for FDA reforms, including enhancing accelerated approval and improving clinical trial diversity — but how much will the legislation change in the coming months and how? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the requirements for FDA, HHS, sponsors and other stakeholders that would come into effect under the House’s proposed user fee legislation and what’s next for the bill. The podcast team also discusses Howard University’s mission to address racial health disparities, and how the university brings a human focus to research that might have otherwise stuck to laboratory models.
Chinese biotechs face regulatory delays for their therapies due to pandemic-related barriers to inspections by Western regulators and FDA’s reluctance to accept China-only data. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a setback for surufatinib from Hutchmed could be a sign of things to come for its China peers. The podcast team also analyzes a flurry of FDA activity and assesses what the IPO by vaccine play HilleVax says about the market for fresh paper. This week’s podcast is sponsored by Kendall Square Orchestra.
The first clinical data from Nkarta’s CAR natural killer cell platform add to the growing evidence that a CAR may provide the efficacy boost NK cell therapies have needed. BioCentury's editors analyze the significance of the data, which drove a 141% gain in the biotech's stock. They also discuss the biopharma legacy of the late Sen. Orrin Hatch, how biopharma companies are coping with the extended lockdown in Shanghai, and takeaways from J.P. Morgan’s Mike Gaito appearance on The BioCentury Show. This week’s podcast is sponsored by Kendall Square Orchestra.
Long-awaited proof of concept for AstraZeneca’s PARP-1-selective therapy opens the door to combination strategies previously limited by hematopoietic toxicity, Senior Editor Karen Tkach Tuzman says on the latest edition of BioCentury This Week. Tkach Tuzman surveys data from the growing DNA damage repair (DDR) field from this year’s American Association for Cancer Research meeting, and the team also discusses the legacy of outgoing NCI Director Ned Sharpless, concerns over McKinsey's work for FDA and life sciences clients and the latest crop of BioCentury Emerging Company Profiles. This week’s podcast is sponsored by Bio€quity Europe.
Positive fund flows and modestly better performance by biotech indexes offer hints that the beginnings of a recovery could be possible in the near term, even as the financing drought grinds on. On a BioCentury This Week Special Report, BioCentury’s editors discuss the conditions, including clinical catalysts and M&A, that could spark a recovery for the biopharma sector. This week’s podcast is sponsored by Bio€quity Europe.
BioCentury's editors break down CMS’s final coverage decision on amyloid mAbs for Alzheimer’s disease, focusing on what the lessons are from Aduhelm’s journey through FDA and CMS, and what sponsors of the next crop of Alzheimer's therapies should expect when seeking approval of their programs. Plus: highlights from the latest translational coverage in BioCentury’s Distillery, a call from FDA’s Patrizia Cavazzoni for increased funding to support regulatory innovation, and takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with EQRx Inc.’s Jami Rubin.
Novartis is prioritizing “high-value,” multibillion-dollar assets as it reorganizes. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the Swiss pharma’s plans to reunite its oncology unit with the rest of its pharma business and carve out a new C-suite post to oversee strategy and growth. Plus: how Merck KGaA is changing the way it is building its pipeline following late-stage clinical disappointments and what to look for at the upcoming Association for Cancer Research (AACR) meeting.
AACR is just around the corner, and new data being presented at the conference details how stakeholders are improving the specificity of CAR T therapies in solid tumors and improving their ability to penetrate the tumor microenvironment. Plus, BioCentury’s editors discuss the upcoming FDA advisory committee for ALS therapy AMX0035 from Amylyx, including FDA’s stance on the efficacy data and the challenges around weighing the safety of a therapy for a patient community in desperate search of new treatments vs. maintaining an efficacy standard for approvals.
The importance of FDA’s approval of Bristol Myers' LAG3 inhibitor Opdualag nivolumab/relatlimab for melanoma, the pharma’s disruptive marketing strategy and what’s next among checkpoints in the clinic headline the latest BioCentury This Week podcast. BioCentury's editors also discuss why there’s still a lot of excitement regarding the IL-2 cancer pipeline despite last week’s setback for Nektar Therapeutics and the paths less traveled to raising money as the downturn grinds on. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.
Chinese immuno-oncology companies are changing how they interact with FDA as they seek approval of PD-1 programs. On this episode of BioCentury This Week, BioCentury’s editors discuss takeaways from a survey of CEOs and R&D heads developing PD-1 or PD-L1 inhibitors about what’s next for their programs. The team also previews translational data expected at next month’s meeting of the American Association for Cancer Research (AACR) and legislation making its way through Congress as the House Energy and Commerce Committee’s health subcommittee prepares to gather. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.
War Pulls Biotech to Ukraine, Out of Russia: BioCentury's editors look at how the worsening crisis in Ukraine is affecting the global life sciences community, and discuss the challenges and tactics for removing Russian capital from biotech VC funds and the takeaways form a Guest Commentary by 4BIO Capital’s Dima Kuzmin that calls for a thoughtful approach to economic disengagement from Russia. Plus: what highly anticipated TROPiCS-02 data means for Gilead's Trodelvy sacituzumab govitecan-hziy and Senior Editor Karen Tkach Tuzman returns for another monthly installment of What’s on Tap in the Distillery. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.
Industry leaders have vowed to disengage with Russia until it stops its invasion of Ukraine and respects its neighbor’s sovereignty. What's the likely impact of their pledge and what are the implications of the crisis in Ukraine for biopharma companies around the globe? Plus: Assessing the latest cut of data for Intellia's pioneering in vivo CRISPR-Cas9 therapy and key takeaways from Washington Editor Steve Usdin’s conversation with ICER’s Steve Pearson on The BioCentury Show. This week’s podcast is sponsored by life sciences investment firm Jeito Capital.
Newly confirmed FDA commissioner Rob Califf will be prioritizing a proactive communications strategy, including combating misinformation about science, whilst guiding FDA through the pandemic and trying to keep the agency above Washington’s political fray. Plus, BioCentury’s editors discuss how late-stage investors are adapting to biotech’s bull market and Amgen’s application of its rapid development strategy to its pipeline. Sponsored by Jeito Capital, a global leading investment company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking innovation. Learn more at Jeito Capital.
Dig deeper into BioCentury’s analysis of these issues and more at BioCentury.
FDA and its advisory panel of oncology experts have repudiated the use of China-only data for regulatory submissions in the U.S. How will China's cancer companies adjust to this new regulatory environment? Plus, BioCentury's editors discuss the upcoming vote on Rob Califf, President Biden's nominee to become the next FDA commissioner, and the latest translational trends in cancer, infectious and neurology as identified BioCentury's Distillery. Sponsored by ICON, the clinical research organization offering flexible partnership model for biotech companies. Learn more at ICON.
Dig deeper into BioCentury's analysis of these issues and more at BioCentury.
Weathering the bear market. Oncology chief’s change in thinking on PD-1 therapies. Plus BioCentury’s 2021 innovative start-ups. This week’s podcast is sponsored by ICON.
This week’s podcast is sponsored by ICON.
BioCentury’s new in-depth conversational series launches with Scott Gottlieb as debut guest. This week’s podcast is sponsored by ICON.
Part two of BioCentury’s 2022 Financial Markets Preview, access to Alzheimer’s mAbs, and translational highlights from the Distillery. This week’s podcast is sponsored by ICON.
BioCentury editors discuss Goldilocks COVID-19 antibody test regulation, vaccine development, and the post-pandemic future.
BioCentury Editors discuss what the latest survey results tell us about how biotechs are managing through the economic downturn, and cover what FDA Commissioner Hahn told BioCentury last week.
How industry, government and academics are joining together to discover, develop and deploy therapies and vaccines.
It has been three months since Chinese scientists revealed the genomic sequence of SARS-CoV-2. In our first episode, “Racing to Create Countermeasures,” BioCentury’s editors discuss progress made by biopharma companies and other researchers in developing diagnostics, therapies and vaccines against the virus that causes COVID-19.
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