BioCentury This Week

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, cystic fibrosis, and other nonsense-mutation diseases. Also this week, emerging company profiles on BrainChild and Cloverleaf.

View full story: https://www.biocentury.com/article/660792

#Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment

0:00 - Introduction
1:13 - Psychedelics at FDA
10:20 - Mike Davis Leads CDER
22:29 - Suppressor tRNAs Advance

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A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the Phase III miss of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big pharma deals analysis, which found industry's largest players leaning into disruptive platforms such as bispecifics, in vivo CAR Ts, siRNAs, and degraders. In Washington, Steve Usdin reports on most-favored nation drug pricing carve-outs and policy pressure on mid-tier biotechs – plus the conspicuous lack of U.S. biotechs coming to the table -- pays tribute to the late Peter Barton Hutt, the former FDA Chief Counsel who shaped foundational elements of modern FDA law.

View full story: https://www.biocentury.com/article/660746

#CardiovascularDisease #DrugPricing #BiotechMA #ClinicalTrials #FDA 

0:00 - Introduction 
1:23 - Novartis Phase III Fallout
18:24 - Annual Pharma Deals Analysis
27:42 - MFN Carve-Outs
32:39 - Remembering Peter Barton Hutt

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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 commissioner and what it signals about FDA independence, and Revolution Medicines' 35-day filing-to-approval timeline under FDA's national priority review voucher pilot.

View full story: https://www.biocentury.com/article/660655

#DrugPricing #FDA #BiotechMA #Oncology #BiopharmaPolicy

0:00 - Introduction
2:14 - MFN Drug Pricing Deals
10:09 - Lilly Acquires Merida
22:22 - FDA Commissioner Pick
30:11 - RevMed's Rapid Approval

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