Ep. 387 - Psychedelics at FDA, Mike Davis’ CDER & tRNAs

Note: This episode was briefly published with an incorrect audio file, which has since been corrected.FDA is prepared to approve psychedelic therapies for chronic psychiatric disorders before sponsors have fully determined how long the effects last or when patients should receive second or subsequent doses. On the latest BioCentury This Week podcast, BioCentury's analysts assess the latest guidance on psychedelics from FDA.The team also discusses takeaways from Michael Davis' first interview as CDER director, plus preclinical advances positioning suppressor tRNA for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. They also highlight Emerging Company Profiles on BrainChild and Cloverleaf.View full story: https://www.biocentury.com/article/660792#Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment0:00 - Introduction1:13 - Psychedelics at FDA10:20 - Mike Davis Leads CDER22:29 - Suppressor tRNAs AdvanceTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 Fallout18:24 - Annual Pharma Deals Analysis27:42 - MFN Carve-Outs32:39 - Remembering Peter Barton HuttTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #BiopharmaPolicy0:00 - Introduction2:14 - MFN Drug Pricing Deals10:09 - Lilly Acquires Merida22:22 - FDA Commissioner Pick30:11 - RevMed's Rapid ApprovalTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #BiopharmaPolicy0:00 - Introduction6:40 - U.S.15:09 - Australia24:00 - China32:14 - EuropeTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #DrugDevelopment00:00 - Introduction03:03 - Moderna11:12 - Genentech obesity deal15:08 - Trump's FDA pickTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #Biopharma00:00 - Introduction02:18 - Venture Rounds12:02 - Drugging β-catenin18:12 - Capricor & FDATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #FederatedLearning00:00- Introduction01:15 - Academic Centers10:42 - Policy Picture15:48 - Grand Rounds Europe Highlights18:01 - Federated Learning28:15 - NASDAQ IPOsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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 #OncolyticVirus00:00 - Introduction00:51 - AZ-BMS Rumors08:07 - Replimune20:46 - PsychedelicsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Argenx the tier-jumping European biotech, believes its proposed $2.2 billion purchase of Forte Biosciences will add a second multi-indication product upon which it can run the strategy that has made autoimmune drug Vyvgart efgartigimod alfa a blockbuster. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the deal and put it in the context of a new cohort of large-cap companies increasingly active in biotech M&A.The analysts also assess how recent releases from Anthropic, NVIDIA, Google, OpenAI and Amazon fit into biopharma R&D workflows — and with one another. Finally, they analyze the 1H26 clinical and regulatory catalyst scorecard, which therapies hit their milestones, which missed, and what’s next through year-end. This episode of the BioCentury This Week podcast has been brought to you by CBRE.View full story: https://www.biocentury.com/article/660296#BiotechMA #ArtificialIntelligence #DrugDevelopment #ClinicalTrials #Biopharma00:01 - Sponsor Message: CBRE01:57 - BioCentury AI Connector05:47 - Argenx Acquires Forte08:06 - Rise of Biotech Buyers13:12 - AI Giants' Tech Stack24:20 - Anthropic Enters Drug Development27:41 - 2026 CatalystTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The departure of U.K. Science Minister Patrick Vallance is a blow for U.K. biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what Vallance’s exit, the appointment of John Healey as Chancellor of the Exchequer and other changes arriving with the new Prime Minister could mean for life sciences in the country. BioCentury’s analysts also discuss an ambitious U.K. data initiative launched this month. The Health Data Research Service is intended to be a single front door to all NHS health records, offering large-scale longitudinal health data across diverse populations.Beyond the U.K., the team turns to companies to watch in Taiwan, what’s next for Biogen’s anti-tau therapy, Eli Lilly’s proposed acquisition of psychedelics company AtaiBeckley, and the latest changes at FDA. This episode of the BioCentury This Week podcast has been brought to you by CBRE.View full story: https://www.biocentury.com/article/660194#Biotech #LifeSciences #UKBiotech #HealthData #FDA00:01 - Sponsor Message: CBRE02:23 - U.K. Leadership Changes09:21 - U.K. Data Initiative10:52 - Taiwan Biotech16:44 - Biogen’s Tau Data27:18 - Lilly’s Psychedelics Takeout28:20 - FDATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text