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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.
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