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)
- 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)
- 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)
- 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)
- US sued by food stamp recipients over restrictions on sugary drinks, candy (Reuters)
- Bayer takes its battle on pesticide liability to Kansas (Reuters)
- 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)
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