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November 4, 2025
by Jason Scott

Recon: Pfizer, Novo escalate bidding war over Metsera; Merck lands $700M from Blackstone to develop investigational cancer drug

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

In Focus: US
  • Experts worry FDA’s credibility is being shredded by scandal and ‘soap opera’ (STAT)
  • Bidding war between Pfizer, Novo Nordisk for obesity startup Metsera escalates (STAT)
  • Breaking: Lilly and Novo near White House deal on obesity drug prices (Endpoints)
  • That $40 Billion Tylenol Deal Is Both Cheap and Risky (Bloomberg)
  • Amgen profit beats estimates, weight-loss data due by year-end (Reuters)
  • Prescription Pulse: More Tidmarsh Fallout (Politico)
  • New FDA turmoil throws agency's reliability into question (Axios)
In Focus: International                                                                                                       
  • Swiss biotech returns to Boehringer Ingelheim to partner on autoimmune T cell engager (Endpoints)
  • US, Canada Face Unwelcome Measles Milestone Due to Outbreaks (Endpoints)
  • Mandatory bird housing imposed in England as bird flu spreads (Reuters)
  • EU Biotech Act: Careful Drafting Needed To Protect SMEs From ‘Over-Regulation’ (Pink Sheet)
Pharma & Biotech
  • Sarepta Therapeutics’ dismal quarter marred by drug failures and a long list of excuses (STAT)
  • A miracle pill for Parkinson’s is 50 years old. Why can’t most of the world get it? (STAT)
  • As pharma pour billions in US manufacturing, CDMOs see future opportunities (Endpoints)
  • Alvotech plant issues foil another FDA review, this time for Teva-partnered Simponi biosimilar (Fierce Pharma)
  • The Tests They Are A-Changing: FDA Takes Action on Biosimilars (FDA Law Blog)
  • Compass Pathways expects earlier FDA approval decision on its psilocybin drug (STAT)
  • Microdosing aims to extend the lifespan of the GLP-1 compounding market (STAT)
  • Jennifer Doudna spinoff aims to turn patients’ immune cells into CAR-T fighters with single shot (STAT)
  • Incyte, Prelude ink rare blood cancer pact; Merck takes back rights to Prometheus asset (Endpoints)
  • Pfizer cuts 11 R&D programs, reports revenue decline (Endpoints)
  • Blackstone to pay Merck $700M to fund development of antibody-drug conjugate (Endpoints)
  • Vertex’s Cystic Fibrosis Sales Beat, as Newer Drugs Miss (Bloomberg)
  • Epilepsy Cell Therapy NRTX-1001 Among Trio Of Drugs To Win EMA PRIME Designations (Pink Sheet)
  • Arcutis adds '90210' star power to skin condition awareness push (Fierce Pharma)
  • Insulet campaign takes aim at workplace challenges for people with diabetes (Fierce Pharma)
Medtech
  • Philips New Orders Rise on Robust Demand in North America (Bloomberg)
  • Dexcom recalls G6 CGM app over software problem (MedTech Dive)
  • Neuromodulation Tech Raises Billions Despite Commercial Uncertainty (MedTech Insight)
  • Surgery-Imaging Firm Ultragreen.ai Starts Gauging Interest for Singapore IPO (Bloomberg)
Food & Nutrition
  • Trump administration says SNAP will be partially funded in November (STAT)
  • Brashears gets confirmation hearing for USDA Undersecretary for Food Safety appointment (Food Safety News)
Government, Regulatory & Legal  
  • UnitedHealth pays its own physician groups 17% more than outside ones, study shows (STAT)
  • GoodRx wants in on TrumpRx as it grows its work with pharmaceutical manufacturers (Endpoints)
  • Florida’s vaccine mandate rollback stirs fear for immunocompromised (The Hill)
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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