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BioCentury This Week: Daily Summaries Delivered
by BioCentury
BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.
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- 6 days ago35 min
Ep. 387 - Psychedelics at FDA, Mike Davis’ CDER & tRNAs
FDA has laid out what it will accept to approve a psychedelic therapy: 12-week efficacy data plus preliminary follow-up. On the latest BioCentury This Week podcast, BioCentury's analysts assess what that means for sponsors navigating trial design with the agency. The team also discusses Michael Davis' first interview as permanent CDER director and what it signals for regulatory stability after a turbulent year, plus preclinical advances positioning suppressor tRNAs as a platform for Duchenne,...
- 1 weeks ago35 min
Ep. 386 - Novartis misses, pharma deals analysis, MFN carve-outs
Novartis' pelacarsen Phase III miss has wiped more than $40 billion in market cap and raised questions about whether the problem is target biology, molecule design, or treatment timing. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardiovascular target, the implications for siRNA versus antisense, and what Novo Nordisk's halted IL-6 inhibitor trials add to a rough week for cardio drug development. The analysts also review BioCentur...
- 2 weeks ago35 min
Ep. 385 - MFN deals, Lilly takeout, FDA pick Overton
Mid-sized biopharma companies are under growing pressure to accept most-favored nation drug pricing deals with the White House. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trade-offs companies face, the litigation risks around mandatory Medicare MFN pricing demonstrations, and what happens to companies that don't sign on. The analysts also discuss Eli Lilly's acquisition of Merida, its thirteenth takeout of the year, Heidi Overton's nomination as FDA commissio...
- 3 weeks ago42 min
Ep. 384 - Back to School Special: The global FIH trials race
China has changed the global narrative on delivering early human clinical data, with a new bar for speed and efficiency. And now drug developers and policymakers around the world have gotten the message and know that this is no time for complacency. On a special edition of the BioCentury This Week podcast, BioCentury's analysts discuss why transformational reform for early clinical development will require rethinking the risk-control paradigm for first-in-human trials. It’s the subject of the...
- 3 weeks ago19 min
Ep. 383 - Moderna, Genentech obesity deal, Trump's FDA pick
A Phase III win for a melanoma vaccine from Moderna and Merck & Co. has opened the door to personalized neoantigen vaccines. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the vaccine’s prospects and the broader implications. The analysts also discuss Roche/Genentech’s deal with Hanmi, which will add to the MNC’s obesity pipeline an asset that the pharma believes could be first in class, and the White House's pick of a Trump loyalist to lead FDA – a move that ha...
- Aug 18, 202625 min
Ep. 382 - Summer’s venture wave; drugging beta-catenin; Capricor & FDA
A baker’s dozen of biotechs shrugged off the summer haze to raise nearly $800 million in venture cash. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the financings, which included money for a potential challenger to Amgen’s blockbuster Tepezza and a new venture from immunology professor Georg Schett with backing from Deerfield Management, Boulevard Bio. The analysts also discuss new approaches to drug cancer’s “undruggable” β-catenin pathway, and whether Capricor’s...
- Aug 11, 202631 min
Ep. 381 - FIH urgency in the U.S. Plus: federated learning, biotech IPOs
Pressure is on FDA, policymakers and academic centers in the U.S. to respond to challenges from China, Australia, and beyond to run first in human trials faster and more efficiently. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how stakeholders in the U.S. are responding to the challenge. The analysts also discuss the next frontiers of federated learning in drug discovery and the latest crop of biotech IPOs on NASDAQ, which raised over $1.2B in strong IPO run last...
- Aug 4, 202632 min
Ep. 380 - AZ-BMS rumors, Replimune, psychedelics
Rumors flew this weekend about a mega-merger of AstraZeneca and Bristol Myers — but would such a deal make sense? On the latest BioCentury This Week podcast, BioCentury’s analysts explain why they aren’t buying it. The team also discusses what lessons can be learned from the regulatory roller-coaster ride of Replimune’s RP1 vusolimogene oderparepvec and psychedelic therapies’ inflection point in treating depression. View full story: https://www.biocentury.com/article/660376 #BiotechMA #FDA ...
About BioCentury This Week
BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.
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