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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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