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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
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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 podcasts@biocentury.com.
RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases.
The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize development of rare disease therapies.
Dig into the BioCentury’s catalyst picks and the new China policy below
• 2026 Catalysts: The rise of RNAi
• 2026 Cardiovascular Catalysts: Lp(a) on the Horizon
• 2026 Obesity Catalysts: Launches, readouts and challengers
• 2026 Catalysts: Breakthrough progress in renal disease
• AZ signals all-in on obesity via CSPC deal for $1.2B up front
• China’s orphan drug exclusivity could bolster market, incentivize development
View full story: https://www.biocentury.com/article/658286
00:00 - Introduction
02:28 - RNAi and Antisense Therapies
06:37 - Neuromuscular and Musculoskeletal
10:33 - Renal Disease Catalysts
22:26 - China's New Orphan Rules
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies.
Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Senior Biopharma Analyst Danielle Golovin discusses a pair of stories from BioCentury’s Emerging Company Profile series: one focused on Yale spinout Bexorg Inc., which is rethinking CNS drug discovery with a whole-human-brain model, and another on Elkedonia S.A.S., a French start-up aiming at ELK1 to reboot neuroplasticity in depression.
View full story: https://www.biocentury.com/article/658189
00:00 - Introduction
03:14 - Speeding China's Innovation
10:36 - Neuro Catalysts
22:01 - Newcos
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector.
View full story: https://www.biocentury.com/article/658154
#BiotechBullMarket #PublicMarkets #BiotechMA #IPOOutlook #FDApolicy
00:00 - Introduction
00:41 - Market Sentiment
07:55 - Biotech's Next Wave
14:47 - Lingering Concerns
23:29 - IPOs
26:47 - M&A
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
Next-generation induced proximity technologies are coming of age after a decade of industry focus on PROTACs. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Senior Biopharma Analyst Danielle Golovin’s four-part analysis of how next-generation targeting chimeras (TACs) are evolving. The analysts assess the $2.2 billion takeout of Rapt Therapeutics by GSK, which gave the pharma an allergy asset that the biotech sourced in China in 2024, and movement in Washington on priority review vouchers, NIH’s budget and the White House’s “most favored nation” drug pricing policy. The analysts also discuss takeaways from their meetings on the sidelines of the J.P. Morgan Healthcare Conference.
View full story: https://www.biocentury.com/article/658112
#InducedProximity #TargetingChimeras #BiotechMA #DrugPricingPolicy #JPMHealthcare
00:00 - Introduction
03:17 - JPM Highlights
09:17 - GSK's Acquisition of RAPT
14:46 - Next-Generation Targeting Chimeras
21:41 - MFN and Pediatric PRVs
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
The J.P. Morgan Healthcare Conference kicked off this week with sunny skies over San Francisco and more financial momentum than the biotech industry has seen in years. On a special “on the road” edition of the BioCentury This Week podcast, recorded on the sidelines of the annual JPM conference, special guests joined BioCentury’s analysts to discuss the biotech ecosystems in Asia.
The wide-ranging conversation spans dealmaking, including the pricing dynamics of assets in China and RNAi’s prospects of becoming the region’s next hot modality; plus the state of the capital markets, the global implications of “China speed” in the clinic, and what’s changing for start-ups in Japan.
Joining BioCentury were Panacea Venture’s James Huang, MayTech Global Investments’ Ingrid Yin, DLA Piper’s Ting Xiao and CBRE’s Matt Gardner.
The podcast was recorded at the 12th East-West Healthcare Reception, hosted by BioCentury, MayTech Global and Panacea.
View full story: https://www.biocentury.com/article/658081
#JPMHealthcare #AsiaBiotech #ChinaBiotech #RNAiTherapeutics #BiotechCapitalMarkets
00:00 - Introduction
02:02 - Split Screen 2026
05:57 - China's Rapid Progress
08:01 - AI and Biotech
16:58 - Deal Prices
22:56 - Public Markets
28:47 - Innovation Across Asia
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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