BioCentury This Week

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 2026 Back to School issue, the 34th edition of an annual analysis that takes on one of the most pressing topics facing the biopharma industry.

View full story: https://www.biocentury.com/article/660629

#ClinicalTrials #FirstInHuman #DrugDevelopment #FDA #BiopharmaPolicy

0:00 - Introduction
6:40 - U.S.
15:09 - Australia
24:00 - China
32:14 - Europe

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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 has revived questions of the agency's independence.

View full story: https://www.biocentury.com/article/660596

#CancerVaccines #Obesity #FDA #Oncology #DrugDevelopment
00:00 - Introduction
03:03 - Moderna
11:12 - Genentech obesity deal
15:08 - Trump's FDA pick

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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 latest regulatory move will give Duchenne muscular dystrophy therapy deramiocel new life at FDA.

View full story: https://www.biocentury.com/article/660539

#BiotechFinancing #DrugDevelopment #BetaCatenin #DuchenneMuscularDystrophy #Biopharma

00:00 - Introduction
02:18 - Venture Rounds
12:02 - Drugging β-catenin
18:12 - Capricor & FDA

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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 week.

View full story: https://www.biocentury.com/article/660433

#ClinicalTrials #BiopharmaPolicy #DrugDevelopment #BiotechIPO #FederatedLearning

00:00- Introduction
01:15 - Academic Centers
10:42 - Policy Picture
15:48 - Grand Rounds Europe Highlights
18:01 - Federated Learning
28:15 - NASDAQ IPOs

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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 #Psychedelics #Depression #OncolyticVirus

00:00 - Introduction
00:51 - AZ-BMS Rumors
08:07 - Replimune
20:46 - Psychedelics

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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