BioSpace

• New Approach Methodologies: Redefining Animal Testing Alternatives

  Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced.  The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing.In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsPatrick Smith, Senior Vice President, Translational Science, CertaraStacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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• Prasad’s Leaked FDA Memo, Alzheimer’s Ups and Downs, Next-Gen Obesity Drugs

  Vinay Prasad’s memo, leaked over the weekend, has sent vaccine makers’ stocks slipping and experts clamoring for more evidence to support the CBER director’s claim that COVID vaccines have led to the deaths of at least 10 children. It’s the latest insult to the vaccine sector from the healthcare administration this year, with other challenges coming on the CDC side, where the recently revamped advisory committee is heading into its next meeting with a brand new chair.  Elsewhere at the FDA, newly promoted Center for Drug Evaluation and Research Director Richard Pazdur has filed the paperwork to retire from the agency just weeks after reportedly reluctantly accepting the position.   Meanwhile, the Alzheimer’s space is buzzing as the 2025 Clinical Trials on Alzheimer’s Disease (CTAD) conference continues in San Diego. Last week saw a mid-stage flop for Johnson & Johnson’s anti-tau candidate and the “definitive” failure of Novo’s GLP-1 semaglutide—which analysts say may actually help uptake of anti-amyloid therapies from Biogen and Eli Lilly. Meanwhile, Roche announced positive results for its latest antibody, putting the pharma back in the game it had once stepped back from in the tumultuous days of Aduhelm.   In the weight loss space, Novo Nordisk revealed ‘competitive’ mid-stage data for its next-gen amycretin, which showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes. Meanwhile, the pricing war for approved and future GLP-1s from Novo and obesity rival Eli Lilly rages on, with Lilly this week announcing another price drop for Zepbound through its LillyDirect self-pay platform.  In BioPharm Executive this week, we review the top venture capital rounds for female-founded biotechs and examine the 2026 biotech market outlook. 

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• Billions More in M&A, Another Bidding War and More FDA Drama

  Acquisitions have ticked up this month as all eyes were on Pfizer and Novo’s fight over Metsera. The past week saw that deal finalized with Pfizer as the winner plus a handful of other M&A stories, including Merck’s $9.2 billion buyout of Cidara Therapeutics and Johnson & Johnson’s $3 billion bet on Halda Therapeutics. Additionally, a separate bidding war has broken out between Lundbeck and Alkermes for sleep biotech Avadel Pharmaceuticals. Outside of M&A, the FDA dominated headlines again this week. The agency effectively closed the loop on one of the messiest stories of the year—Sarepta’s gene therapy Elevidys—when it formally added a black box warning for serious liver toxicities and risk of death and removed the nonambulatory indication from the label. The agency will also require that the company complete a postmarketing observational study of around 200 patients. This happened just as Richard Pazdur accepted the role of director of the Center for Drug Evaluation and Research (CDER) that was recently vacated by George Tidmarsh amidst conflict with Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad. By all accounts, Pazdur, a 26-year FDA veteran, is a highly respected and thoughtful regulator, and sources told BioSpace that if Prasad tries to supersede Pazdur’s authority, “there will be hell to pay and resignations to be handed in.” In other FDA drama, FDA Commissioner Marty Makary is apparently butting heads with Health Secretary Robert F. Kennedy Jr. Meanwhile, the agency revealed details of its plausible mechanisms pathway teased by Makary earlier in his tenure. Finally, in Biopharm Executive this week, check out our deep dives into GLP-1 pricing. Coming off Trump’s deal with both Eli Lilly and Novo Nordisk to offer their GLP-1s at a lower cost through the president’s new direct-to-consumer platform, Novo CEO Maziar Mike Doustdar announced a sale on its company’s products. Bargain bin pricing like this so early in a drug’s market life is unprecedented. It’s changing the investment calculations for the next-generation of obesity treatments. 

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• How Biotech Funding is Changing Executive Search and Hiring Processes

  A lean funding environment has changed how biotechs approach workforce organization and executive hiring. Searches are becoming more targeted and intentional, and accountability–both for employers and candidates–is high. In this episode of Denatured, Leslie Loveless of Slone Partners describes how biotechs should approach building their executive teams, working with boards and investors to make decisions that will enable growth. She also discusses how the search and hiring processes has changed for both employers and candidates.This episode is presented in partnership with Slone Partners. HostChantal Dresner, Vice President of Marketing, BioSpaceGuestLeslie Loveless, Co-CEO and Managing Partner, Slone PartnersDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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• Pfizer Wins Metsera, Trump Strikes GLP-1 Pricing Deal, FDA Awards More Priority Vouchers

  One of biopharma’s most memorable bidding wars finally came to an end on Friday—with Metsera right back in the arms of its original suitor, but with Pfizer paying around $10 billion for the rights to the obesity biotech, a nearly $3 billion increase over its original bid. But while Novo Nordisk may have bowed out of that race, the company still made headlines this past week, with CEO Maziar Mike Doustdar joining Eli Lilly head David Ricks at the White House on Thursday to announce a deal that will see their GLP-1 drugs offered at about $350 per month.   This marks a significant discount to the current list prices of $1086 and $1350 for Lilly’s obesity drug Zepbound and Novo’s comparator Wegovy, respectively. No matter how low they go, however, the GLP-1 leaders can still be undercut by compounders, Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, told BioSpace this week.   Speaking of Lilly, the Indianapolis-based pharma had a busy week, reporting 20% weight loss in a mid-stage study of its amylin agonist eloralintide that William Blair analysts said “validates [the] amylin agonist class.” Lilly also netted two new partners, inking a $1.2 billion RNAi pact with SangeneBio to target metabolic diseases and licensing a genetic eye disease therapy from MeiraGTx Holdings for up to $475 million.   On the regulatory front, the FDA awarded the second round of priority review vouchers under its new Commissioner’s National Priority Vouchers program. Unlike the first cohort of vouchers, which was announced in October, this group mostly consisted of products already on the market—with the exception of Lilly’s orforglipron.   Finally, BioSpace dives into one the hottest trends in the immunology and inflammation (I&I) space—pipeline-in-a-product. Possibly motivated by blockbuster drugs like AbbVie’s Skyrizi and Rinvoq and Regeneron and Sanofi’s Dupixent, companies are optimizing shots on multiple goals in this lucrative space.  

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