BioCentury This Week

The second ousting of Vinay Prasad from FDA in the past eight months won’t lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what’s next for the agency following his departure.
BioCentury’s editors also discuss the next wave of therapies for idiopathic pulmonary fibrosis, including whether new candidates might go beyond slowing disease to halt or even reverse progression, the biological complexity that makes fibrosis so challenging, and what the 20-plus Phase II programs could teach the field about fibrosis biology.
Also up for discussion were recent clinical wins — as well as more complicated readouts — from psychedelic therapies; plus the latest data updates from obesity treatments, with a focus on amylin agonists.

View full story: https://www.biocentury.com/article/658698

#FDA #IdiopathicPulmonaryFibrosis #PsychedelicTherapies #ObesityDrugs #AmylinAgonists

00:00 - Introduction
01:56 - Prasad's Departure
15:27 - Fibrosis Therapies
23:35 - Psychedelics Clinical Catalysts
28:24 - Obesity Updates

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Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully stronger can emerge.
The analysts also discuss BioCentury’s latest Rare Disease Spotlight, which focuses on a wave of therapies aiming to activate retinal function in Stargardt disease patients.
Turning to FDA, BioCentury Washington Editor Steve Usdin discusses recent public statements by FDA Commissioner Marty Makary, questions about Vinay Prasad’s future, and the plausible mechanism pathway.
View full story: https://www.biocentury.com/article/658606
 #GlobalBiopharma #ChinaBiotech #RareDisease #StargardtDisease #FDAPolicy 
00:00 - Introduction
02:47 - Multipolar Biopharma World
13:39 - Rare Disease Spotlight
25:15 - Makary Remarks
31:14 - Plausible Mechanism Framework
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Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline.
The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials.
Turning to Washington, Steve Usdin offers his takeaways from last week’s PhRMA Forum, which focused on China and the Trump administration’s most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA’s about-face on the recent vaccine application from Moderna.

View full story: https://www.biocentury.com/article/658516

#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA

00:00 - Introduction
02:34 - Gilead's Arcellx Buy
11:14 - ctDNA Surrogate Endpoints
21:59 - PhRMA Forum Takeaways
29:19 - FDA Moderna U-turn

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As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury’s Lauren Martz assesses how the oral SERD landscape is evolving.
Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay Prasad, FDA’s CSO, CMO, and director of CBER.

View full story: https://www.biocentury.com/article/658455

#TargetedProteinDegradation #OralSERDs #OncologyDrugDevelopment #FDASetbacks #CBER

00:00 - Introduction
03:12 - Oral SERD Spotlight
11:40 - Setbacks at FDA
15:12 - Disc Medicine CRL

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2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed.
Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how the spending bill signed into law last week is a rebuke to proposed White House biomedical cuts.
And Executive Editor Selina Koch unpacks her interview on The BioCentury Show podcast with neuroscientist and Seaport Chair Steven Paul, noting that while serendipity drives drug discovery in psychiatry, it’s engineering that gets it across the finish line.

View full story: https://www.biocentury.com/article/658367

#BiotechFinancing #SeriesAFunding #VentureCapital #DrugDiscovery #BiopharmaPolicy

00:00 - Introduction
02:15 - Start-up Spotlight
11:03 - Compounded Wegovy
18:10 - Congress Rebuffs Trump Cuts
23:50 - Steve Paul on Neuropsychiatry

To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected].
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