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October 30, 2025
by Jason Scott

Recon: Novo Nordisk, Pfizer make dueling offers for obesity drugmaker Metsera; Zepbound and Mounjaro top Keytruda as world’s top-selling drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • How Moderna, the company that helped save the world, unraveled (STAT)
  • Eli Lilly’s weight loss and diabetes drug tops Keytruda as world’s best-selling medicine (STAT)
  • Senate hearing for Casey Means, Trump’s surgeon general pick, is postponed after she goes into labor (STAT)
  • Scientists had to change more than 700 grant titles to receive NIH funding. Health disparities researchers fear what’s next (STAT)
  • Stakeholders Advocate for FDA Modernization In Senate Biotech Hearing (MedTech Insight)
  • US FDA places clinical hold on Intellia's gene therapy trials; shares fall (Reuters)
In Focus: International                                                                                                       
  • Antibiotics Must Cost More Than M&Ms, Sandoz Tells Governments (Bloomberg)
  • How The EU Biotech Act Could ‘Level The Playing Field’ For SMEs (Pink Sheet)
  • EMA To Clarify When Adult Data Can Spare Children From ‘Unnecessary’ Crohn’s Trials (Pink Sheet)
  • Broader EU Influences Likely To Impact Imminent EU Revision Document (MedTech Insight)
  • China Eyes First-In-Class Blockbuster Drugs In Display of ‘Strategic Purpose’ (Pink Sheet)
  • Roche Sees China Drag Peaking In 2025 As Diagnostics Bets On Innovation Pipeline (MedTech Insight)
Pharma & Biotech
  • Novo Nordisk makes offer for obesity-focused Metsera, aiming to outbid Pfizer (STAT) (Reuters)
  • Biotech might be tiny but the dealmaking is mighty (STAT)
  • FDA moves to ease path for biosimilars as Trump seeks to cut drug costs (STAT)
  • Bristol Myers beats quarterly revenue estimates on strong Opdivo sales (Reuters)
  • Bristol Myers tries to temper anxiety over upcoming Cobenfy readout, unveils suite of PD-1xVEGF bispecific trials (Endpoints)
  • National Resilience secures $825M in funding; Regeneron details US manufacturing plans (Endpoints)
  • Tectonic shares rise on back of Phase 1 heart failure data (Endpoints)
  • Evommune plans to raise about $150M in IPO for inflammatory diseases (Endpoints)
  • Goodbye, Middleman. Hello, Littleman. (Endpoints)
  • Boehringer licenses preclinical program from Kyowa Kirin; Savara makes a royalty deal (Endpoints)
  • Biogen Cuts Profit Guidance After Deals to Bolster Pipeline (Bloomberg)
Medtech
  • Baxter cuts annual profit forecast on persistent hurricane impact; shares hit 20-year low (Reuters)
  • Forget the Fed, Trade and the Shutdown. For Markets, It’s All About AI (Bloomberg)
  • Medline files for initial public offering (MedTech Dive)
  • CMS grants NCD for renal denervation, benefiting Medtronic, Recor (MedTech Dive)
  • Zimmer wins FDA’s breakthrough status for tech to prevent joint infections (MedTech Dive)
  • Thermo Fisher to acquire clinical trial data firm Clario for $8.9B (MedTech Dive)
Food & Nutrition
  • Luminoah Aims To Deliver Personalized, Data-Driven Nutrition And Dignity For Tube-Fed Patients (MedTech Insight)
  • 25 states sue Trump administration over SNAP suspension (Food Dive)
Government, Regulatory & Legal  
  • Trump cuts have decimated the federal addiction and mental health agency (STAT)
  • Biden’s law sets Trump up for success in negotiating cheaper Medicare drug prices (STAT)
  • FDA criticism of MDMA-assisted therapy is an opportunity for psychedelic medicine (STAT)
  • Cigna Plunges on Expected Pressure in Pharmacy Benefit Segment (Bloomberg)
  • Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon (Pink Sheet)
  • US Advanced Health Projects Agency Launches Personalized Medicine Push (Pink Sheet
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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