Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA is urged by advocacy group to ban DTC prescription drug ads (STAT)
- FDA staff and peptide enthusiasts set to clash at advisory panel (STAT)
- Hims & Hers stands to gain if the FDA loosens restrictions on peptides (Reuters)
- Filing of bipartisan Senate bill boosts momentum for office of men’s health (STAT)
- BeOne announces $300 million expansion of US manufacturing facility (Reuters)
In Focus: International
- Congo’s Ebola outbreak has killed over 1,000 people (STAT)
- ‘Cochlear implant for blindness’ debuts in Europe, could launch in U.S. in 2027 (STAT)
- MercadoLibre pitches in-house pharmacy to Chile after launch in Brazil (Reuters)
- Roche says it is thoughtful on token use for AI, shelves a drug from Carmot buy (Endpoints)
Pharma & Biotech
- New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit (STAT)
- Updated: Lilly's triple agonist heads to regulators after two more Phase 3 obesity wins (Endpoints)
- New study supports testing of Merck’s Ebola vaccine in DRC outbreak (STAT)
- Biogen bets newly acquired Apellis can paper over Leqembi's disappointing sales into 2027 (Endpoints)
- For Novartis' CEO, China deals aren't a strategy shift — just where the science is (Endpoints)
- Exclusive: Obesity biotech Verdiva hires ex-Metsera CMO as crucial readouts near (Endpoints)
- West Pharma raises profit forecast on strong demand for injectable drug components (Reuters)
- AI shortens drug discovery to around 1 year in China, Insilico CEO says (Reuters)
Medtech
- Quest Diagnostics raises annual forecast on testing demand (Reuters)
- J&J gets FDA authorization for Ottava robot, teeing up competition with Intuitive (MedTech Dive)
- Time runs out for Vicarious Surgical (MedTech Dive)
- FDA Invites Digital Health Industry To Apply For Grants Supporting Drug Development Research (MedTech Insight)
- Whoop hires FDA digital health committee chair as chief medical officer (MedTech Dive)
- AiM Medical Robotics names new CFO (MedTech Dive)
- Medtronic adds real-time AI to Hugo robot (MedTech Dive)
- Philips wins FDA clearance for new pulse oximeter (MedTech Dive)
- Cancer Diagnostics Breached At Abbott As 2026 Medtech Cyberattack Run Continues (MedTech Insight)
- Ability Neurotech Moves Implantable, Batteryless BCI Into First-In-Human Trial (MedTech Insight)
Food & Nutrition
- US poultry firm recalls nearly 1.6 million dozen eggs over potential salmonella (Reuters)
- Gen Z isn’t drinking less after all (Food Dive)
Government, Regulatory & Legal
- Cigna says AI tools to save customers $200 million in medical expenses over three years (Reuters)
- What’s behind the proposed pullback on remote patient monitoring (Endpoints)
- Teladoc is moving beyond its single-visit roots with new launch (Endpoints)
- Compliance Fears Are Stalling AI In Medtech Sales, Even As Sales Reps Who Use It Outperform (MedTech Insight)
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.