BioCentury This Week

FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative.
BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson & Johnson, which is buying Firefly Bio.
The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center.

View full story: https://www.biocentury.com/article/659699

#FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS

01:23 - Grand Rounds Seattle Takeaways
04:43 - FDA's New Leaders
11:48 - FDA's Real Time Trials Pilot
20:40 - Servier Bets on Neuro
25:33 - Lilly's Deal Spree
30:21 - Dealmaking Roundup

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Revolution Medicines continues to impress with more pancreatic cancer data, earning a standing ovation at ASCO over the weekend. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the detailed data for the company’s daraxonrasib, Akeso’s Harmoni-6 readout, as well as other results from the meeting. BioCentury’s analysts then argue that U.S. biotech executives and policymakers should embrace the challenges and opportunities that come with the rise of innovation in China — rather than sticking their heads in the sand. They also discuss why leaders of the U.S.’s biggest drug companies should use their influence to stop an OMB proposal that threatens the foundations of U.S. science. Plus: takeaways from BioCentury's conversation with Alkermes CEO Richard Pops on The BioCentury Show.

View full story: https://www.biocentury.com/article/659629

#ASCO #PancreaticCancer #BiotechInnovation #ChinaBiotech #DrugDevelopment

00:00 - Introduction
01:49 - ASCO: RevMed
06:50 - ASCO: Akeso
16:33 - China U.S. Biotech Rivalry
24:15 - Science Under Threat
36:29 - Richard Pops Takeaways

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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At ASCO among presentations focused on pancreatic cancer innovation beyond KRAS; however, abstracts for the cancer conference also highlight ADCs, bispecifics and diagnostics that are broadening the field’s approach to the cancer. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Revolution’s daraxonrasib, other readouts to watch for in pancreatic cancer and what else is on BioCentury’s radar at this year’s American Society of Clinical Oncology meeting.

BioCentury’s analysts also discuss a push by China hawks in Congress to get the Trump administration to invoke national security powers to narrow Chinese life sciences companies’ access to U.S. markets, technology and capital; an initiative by Rep. Jake Auchincloss (D-Mass.) that seeks to modernize how clinical trials are conducted in the U.S.; and a BioCentury analysis on new antibody-drug conjugate linker techniques. This episode of the BioCentury podcast is brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659581 

#Biopharma #ASCO2026 #PancreaticCancer #ClinicalTrials #ADCInnovation
00:01 - Sponsor Message: Jeito Capital
02:26 - ASCO Preview
14:24 - U.S. China Policy
22:48 - Modernizing U.S. trials
27:17 - Optimizing ADC Linkers
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Marty Makary wasn’t the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who’s in, who’s out and what’s next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term.
BioCentury’s analysts also discuss the new obesity targets that came to light at last week’s annual meeting of the European Congress on Obesity, the market for biotech IPOs, and the emergence of degrader-antibody conjugates. DACs pair the tissue-targeting logic of antibody-drug conjugates (ADCs) with the catalytic activity of protein degraders. 3C Therapeutics is the latest entrant to the field, pitching its TriCore platform as a modular backbone for DAC generation. This episode of the BioCentury podcast is brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659510

#FDA #ObesityDrugDevelopment #BiotechIPO #DACs #Biopharma

00:01 - Sponsor Message: Jeito Capital 
02:53 - FDA Leadership Shakeup
10:35 - Obesity Target Hunt
16:07 - Biotech IPOs
20:02 - Degrader-antibody Conjugates
28:42 - Serif: Non-viral DNA

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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China’s speed in generating first-in-human data has catalyzed a race across the globe to reshape regulatory requirements to compete. BioCentury’s analysts, along with special guests Detlev Mennerich, head of Boehringer Ingelheim Venture Fund, and Mehdi Ainouche, partner at Jeito Capital, discussed where Europe fits in that landscape and other takeaways from the 26th annual Bio€quity Europe conference in Prague. This special episode of BioCentury This Week has been brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659450

#EuropeanBiotech #ClinicalDevelopment #BiopharmaInnovation #DrugDevelopment #LifeSciencesStrategy

00:01 - Sponsor Message: Jeito Capital 
03:14 - China’s Speed Challenge
04:08 - Europe’s Clinical Trial Opportunity
11:48 - Speed vs. Capital Efficiency
15:52 - Takeaways from Richard Pazdur
19:58 - FDA Uncertainty and Global Alternatives
26:50 - Biopharma M&A Outlook
33:34 - The Next Wave of Science

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