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November 10, 2025
by Jason Scott

Recon: Metsera plunges after accepting Pfizer’s $10B offer; Eli Lilly partners with MeiraGTx's for eye disease gene therapy

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

In Focus: US
  • Is the White House’s deal with pharma on GLP-1 drugs a game changer? (STAT)
  • Fate of ACA subsidies still clouded after deal to reopen the government (STAT)
  • US FDA Begins ‘Competitive Search’ For New Drugs Center Director (Pink Sheet)
  • Metsera falls after accepting up to $10 billion offer from Pfizer (Reuters) (Endpoints)
  • Eli Lilly signs deal for MeiraGTx's gene therapy for severe eye disease (Reuters) (Endpoints)
  • PDUFA VIII: FDA Pilot Programs, Workforce Challenges Could Shape Renewal Debate (Pink Sheet)
  • Makary And Oz Tout Successes At Their Respective Agencies, Say They Are Breaking Down Walls (MedTech Insight)
  • Novartis opens new plant in California to make cancer drugs (Reuters)
In Focus: International                                                                                                       
  • Canada loses measles elimination status — as does the entire Americas region (STAT)
  • German online drug retailer Redcare Pharmacy names Hendrik Krampe as CFO (Reuters)
  • Germany's Siemens to set out plan for $41 billion Healthineers stake (Reuters)
  • India Sets Sights On ‘First-In-World’ Medtech Innovation (MedTech Insight)
  • Novo Nordisk, Emcure to launch weight-loss drug under new brand in India (Reuters)
  • Under Pressure: How To Safeguard The EU Responsible Person (MedTech Insight)
Pharma & Biotech
  • Weight-loss drug developers line up to tap lucrative market as competition heats up (Reuters)
  • Roche reports two Phase 3 wins for its BTK inhibitor in multiple sclerosis (Endpoints)
  • Merck’s pill to reduce cholesterol on top of statins matches results from injectables (STAT)
  • How Regulatory Horizon Scanning Works In The EU, UK & Switzerland (Pink Sheet)
  • US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says (Pink Sheet)
  • Ex-Lilly Diabetes leaders hunt for new obesity drugs at VC firm aimed at 'advancing the science' (Endpoints)
  • Catalent lays off more gene therapy workers in Baltimore (Endpoints)
  • Cogent soars on back of Phase 3 success in stromal tumors (Endpoints)
  • AnaptysBio reports Phase 2 fail in ulcerative colitis; Lyell's CAR-T licensing deal (Endpoints)
  • CRISPR Therapeutics’ gene editing therapy halves cholesterol and triglycerides in early trial (Endpoints)
  • Ionis claims curative potential for Tryngolza in severe triglyceride disease (Endpoints)
Medtech
  • Microsoft launches 'superintelligence' team targeting medical diagnosis to start (Reuters)
  • Exclusive: AI biotech Iambic raises $100M, expects three drugs in clinic in 2026 (Endpoints)
  • MMI tackles Alzheimer’s; SS Innovations advances telesurgery (MedTech Dive)
  • Synchron raises $200M to prepare for brain computer interface launch (MedTech Dive)
  • Olympus to cut 2,000 jobs in endoscopy reorganization (MedTech Dive)
Food & Nutrition
  • Does coffee mix with AFib, and other new data from heart meeting (STAT)
  • At AHA meeting, CRISPR data gleamed but ‘food as medicine’ spoke to the now (STAT)
Government, Regulatory & Legal  
  • It’s time to fundamentally rethink how America pays for health care (STAT)
  • Trump renews a Republican battle cry: Repeal Obamacare (STAT)
  • Ninth Circuit Sends USDA’s Agricultural Marketing Service (“AMS”) Back to Drawing Board on Some Aspects of the BE Labeling Rule (FDA Law Blog
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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