Ep. 270 - Temple’s FDA Legacy. Plus: Chinese Innovation & Novo Obesity Data

Can biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury’s editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn’s latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients.Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year’s worth of wrangling over the Biosecure Act, and Executive Editor Selina Koch breaks down readouts from Neumora on its KOR antagonist navacaprant to treat major depressive disorder and Axsome Therapeutics for its AXS-05 to treat agitation in Alzheimer’s patients. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/654620 00:01 - Sponsor Message: ICON Biotech01:51 - Biotech's Repeating Challenges10:52 - Biotech in the New Year23:07 - Beyond Biosecure28:10 - Neurology ReadoutsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound.View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast00:00 - Introduction02:03 - Bob Temple's Legacy16:13 - China's Academic Innovation26:20 - CagriSema Obesity DataTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.View full story: https://www.biocentury.com/article/65385800:00 - Introduction03:01 - Capital Markets Outlook06:01 - M&A15:19 - Breaking Down Deals24:29 - AsiaTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Lately, it appears some biotech VCs have hit a ceiling, capping their new funds at or below the amount of their previous vehicles, says Paul Bonanos on the latest BioCentury This Week. Bonanos and his BioCentury editorial colleagues discuss what’s behind the trend as they assess VC fundraising in this post-‘supercycle’ era. The editors also evaluate the state of play for venture-backed obesity plays and which VCs are active in the space, as well as takeaways from the latest BioCentury Show podcast featuring Aoife Brennan, CEO of Climb Bio. Finally, the team features the new book from long-time biotech executive and current SV Health Investors partner Tim Harris, In Pursuit of Unicorns: A Journey through 50 Years of Biotechnology.View full story: https://www.biocentury.com/article/65448800:00 - Introduction02:08 - Trends in VC Funds12:16 - Obesity Start-ups19:46 - The BioCentury Show with Aoife Brennan26:50 - Tim Harris' New Book: In Pursuit of UnicornsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now.View full story: https://www.biocentury.com/article/65442000:00 - Introduction01:42 - Biosecure Setback10:01 - Novartis' $1B PTC Deal 16:28 - KCC2 ActivationTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval.View full story: https://www.biocentury.com/article/65436300:00 - Introduction01:08 - Trump's NIH Pick12:13 - Multi-targeted CAR Ts19:26 - Biotech FDA ApprovalsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.View full story: https://www.biocentury.com/article/65431900:00 - Introduction00:32 - Jefferies Conference Takeaways06:25 - Trump Nominations17:41 - Biosecure Act Update21:01 - Pharma in ObesityTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Giving RFK Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor’s Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way.BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment, and the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: BioNTech's acquisition of Biotheus, and Merck's licensing of global rights to a LaNova asset.View full story: https://www.biocentury.com/article/65423300:00 - Introduction01:12 - RFK Jr. & HHS13:15 - Blenrep's Comback19:25 - China DealsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what’s known about the allegations and whether the situation could affect other MNCs operating in the country.View full story: https://www.biocentury.com/article/65415700:00 - Introduction01:01 - Prepping for Trump09:41 - Alzheimer's Ethics17:44 - AstraZeneca's Challenges in China21:51 - Myths and MisperceptionsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.View full story: https://www.biocentury.com/article/65407500:00 - Introduction01:23 - CTAD: Anti-amyloids14:22 - CTAD: UCB's tau data19:47 - FDA & the Election28:16 - China Summit DebriefTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text