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March 12, 2026
by Jason Scott

Recon: Lilly warns of impurities in compounded versions of its weight-loss drugs; Abivax denies rumors of takeover by AstraZeneca

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • It’s the 50th anniversary of the US biotech industry. What will the next 50 years look like? (STAT)
  • The FDA is targeting telehealth marketing of GLP-1 drugs. Who’s prescribing them? (STAT)
  • RFK Jr.’s advisers had a plan to target covid shots. Then it fell apart. (The Washington Post)
  • How GLP-1 weight loss compounders reshaped the drug industry (Endpoints)
  • FDA merges adverse event trackers into one database, including vaccine side effects (Endpoints)
  • FDA Signals Potential Updates to SUPAC Guidances—Comments Due June 1, 2026 (FDA Law Blog)
  • Viatris settles lawsuit over use of woman's 'immortal' cells to power drug research (Reuters)
  • One-third of Americans cut back on other expenses to cover healthcare in 2025, survey shows (Reuters)
In Focus: International
  • Eli Lilly to invest $3 billion in China, seeks approval for weight loss pill (Reuters)
  • EU Notified Bodies Warn MDR/IVDR Amendments Will Deliver Lower Levels Of Patient Safety (MedTech Insight)
  • French Health Startup Alan Valued Above €5 Billion After Raise (Bloomberg)
  • Haleon Bets on Asia (Bloomberg)
Pharma & Biotech
  • Lilly warns of impurity risk in certain compounded forms of Mounjaro and Zepbound (Endpoints) (Reuters)
  • Is Aldeyra Therapeutics waving red flags with consequences? (STAT)
  • After touching the $1T club, Eli Lilly CEO David Ricks is making the moves to stay there (Endpoints)
  • Novo Holdings’ assets fell by a third in 2025 as Novo Nordisk’s value sank (Endpoints)
  • Evotec plans up to 800 job cuts, four site closures in next phase of reorganization (Endpoints)
  • RA Capital, Forbion appear to back Harbour's CTLA-4 partner Solstice (Endpoints)
  • Abivax spokesperson denies takeover rumors reported by French media (Reuters)
Medtech
  • Stryker investigating cyberattack that caused widespread outage (MedTech Dive)
  • Advita Ortho receives warning letter related to shoulder system (MedTech Dive)
  • Insulet posts clinical data on fully closed-loop insulin delivery system (MedTech Dive)
  • Vitestro raises $70M to ready blood collection robot for US launch (MedTech Dive)
  • FDA Weighs Second Citizen Petition On Bamboo Health’s NarxCare (MedTech Insight)
  • FDA Announces May Rollout For MAUDE Replacement (MedTech Insight)
  • Agilent Pays $950M for Biocare Medical To Expand Pathology Reach (MedTech Insight)
Food & Nutrition
  • US sued by food stamp recipients over restrictions on sugary drinks, candy (Reuters)
  • Bayer takes its battle on pesticide liability to Kansas (Reuters)
Government, Regulatory & Legal
  • US Medicare Proposes Buy American Rx Incentives, But What Is A ‘Domestic’ Medicine? (Pink Sheet)
  • This billionaire wants to make science better, especially for AI (STAT)
  • AI agents are rapidly spreading in health care, but validation is lacking (STAT)
  • Momentum builds for a federal office of men’s health focused on disease prevention (STAT)
  • I’m an NIH whistleblower. The scientific community cannot afford to avoid politics (STAT)
  • A top biotech VC quietly helped Epstein’s ‘great friend’ make a comeback (STAT)
  • 'Closed-loop' AI clinical care is coming soon, startups predict (Endpoints)
  • CVS' Aetna pays $117.7 million to settle US claims it defrauded Medicare (Reuters)
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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