AbbVie's $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains.
The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA.
Finally, they discuss China NMPA’s first-ever approval of a CAR T for solid tumors, satricabtagene autoleucel (satri-cel) from Carsgen.

View full story: https://www.biocentury.com/article/659864

#BiotechMA #Immunology #FDA #CART #ChinaBiotech

00:59 - AbbVie Buys Apogee
05:20 - uniQure U-turn
09:02 - FDA Reversals
12:32 - Tzield Memo
20:53 - Solid Tumor CAR T Approval

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Biotech IPOs that are getting out remain hot — but will that continue into the fall? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for fresh biotech paper on NASDAQ, including the $770 million debut by  Parabilis, the largest IPO in the sector’s history.
The analysts also discuss the Biosecure Act and U.S. policy toward China; the cachexia pipeline; and BioCentury’s updated Innovation Distillery.

View full story: https://www.biocentury.com/article/659773

#BiotechIPO #NASDAQ #BiosecureAct #Cachexia #ChinaBiotech 

00:36 - Innovation Distillery
03:56 - Biotech IPOs
10:13 - Biosecure Act, WuXi AppTec
16:03 - Cachexia Pipeline
22:03 - Ouster for RFK Jr.?

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Getting into the clinic fast to de-risk assets has become the name of the game in biotech, and at the academia-industry interface, too.
From AI to NAMs to starting a Phase I trial in the U.S., BioCentury’s 3rd Grand Rounds-U.S. conference brought together academic innovators, biopharma leaders and early-stage investors to debate key bottlenecks in translation and how to make early-stage R&D investible.
Sam Blackman, entrepreneur in residence at GV and co-founder of Day One Biopharmaceuticals, and Aaron Coe, managing director of innovation for the Allen Institute, joined BioCentury’s analysts on stage last week in Seattle for a podcast recording to wrap up Grand Rounds and discuss key takeaways from the event.

Editor’s note: We invite you to join BioCentury and Regional Host Chairs Forbion and BGV at our next edition of BioCentury Grand Rounds, scheduled for Sept. 23-25 in Amsterdam.

View full story: https://www.biocentury.com/article/659729

#TranslationalScience #DrugDevelopment #BiopharmaInnovation #AcademicInnovation #GrandRoundsUS

00:53 - World-Class Regional Hosts
02:56 - Building Grand Rounds Community
05:21 - Two Nobels, One City
07:43 - AI Goes End-to-End
09:47 - The Data Problem
14:12 - AI, Animals, Australia
19:53 - Study Startup Bottlenecks
26:11 - Early Science Investability

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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

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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

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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

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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

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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

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Marty Makary’s hold on the top job at FDA is slipping, with White House leaks about President Donald Trump’s displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him.
BioCentury’s analysts then discuss solutions to AAV’s redosing problem, which could reignite industry interest in a modality that has fallen out of favor, and other topics in the spotlight at this week’s American Society of Gene and Cell Therapy annual meeting. The analysts also discuss opportunities to attend and present academic posters at the third BioCentury Grand Rounds U.S. conference June 3-5 in Seattle. This episode of the BioCentury This Week podcast has been brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659426

#FDA #GeneTherapy #AAV #CellTherapy #Biopharma

00:01 - Sponsor Message: Jeito Capital
01:43 - Bio€quity Europe Prague Highlights
04:54 - Makary on Thin Ice
14:37 - Grand Rounds Poster Pitch
16:40 - AAVs at ASGCT

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UCB is the latest biopharma player to consummate a multibillion-dollar deal amid a surge in biotech M&A activity, acquiring Ken Song’s Candid Therapeutics, one of the leading T cell engager companies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $2 billion takeout and the opportunity in the TCE space.
They also assess the drug development landscape for leukodystrophies and the market for biotech IPOs on NASDAQ, where a trio of biotechs exceeded expectations last week, lifting hopes that the window for new listings is broadening. Looking ahead to June, the analysts also preview the third BioCentury Grand Rounds U.S. conference. This episode of the BioCentury This Week podcast was brought to you by Jeito Capital.

View full story: https://www.biocentury.com/article/659365

#BiotechMA #TCellEngagers #Leukodystrophy #BiotechIPO #TranslationalScience

00:01 - Sponsor Message: Jeito Capital
02:19 - Grand Rounds Seattle
12:47 - UCB’s Candid Buy
20:27 - Leukodystrophies Pipeline
27:22 - Biotech IPOs

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