Recon: Lilly to buy three vaccine makers for up to $3.8B; Brazil approves first generic version of Ozempic

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

In Focus: US

• How Kyle Diamantas defied expectations as he rose to lead the FDA (STAT)
• 8 former CDC directors: Reform PEPFAR, don’t dismantle it (STAT)
• US FDA advisers to weigh updating 2026-27 COVID vaccines to target XFG variant (Reuters)
• Three vaccine biotechs to be bought by Lilly for up to $3.8B (Endpoints)
• Old Drugs, New Tricks: FDA’s Drug Repurposing Initiative (FDA Law Blog)

In Focus: International

• MHRA’s Premarket SI: Agency Foresees No Major WTO Roadblocks (MedTech Insight)
• NICE Says Advanced Liver-Preserving Devices Will Boost Transplant Equality (MedTech Insight)
• Brazil Clears First Generic Copy of Novo Nordisk’s Ozempic Shot (Bloomberg)
• WHO chief says fast-moving Ebola epidemic is outpacing response efforts (Reuters)
• Ebola Vaccine From Oxford Covid Team Nears Production for Trials (Bloomberg)
• Ebola patients flee in attacks on Congo health facilities (Reuters)

Pharma & Biotech

• Eli Lilly says Verve’s gene editor lowers cholesterol levels in early study (STAT)
• An AI biotech CEO sets the record straight on AI drug development hype (STAT)
• Exclusive: Protuoso gets $9.5M to build the next hub-and-spoke antibody developer (Endpoints)
• Astellas’ five-year plan includes chasing record sales and cost cuts (Endpoints)
• Adtech company Swoop buys pharmacy startup NimbleRx (Endpoints)

Medtech

• Medical product maker Convatec warns of higher cost from Iran War (Reuters)
• Olympus expands in cancer tech with $270M buy of BioProtect (MedTech Dive)
• Beta Bionics to launch its first insulin patch pump to compete with Insulet (MedTech Dive)
• Ōura files for IPO amid healthcare push (MedTech Dive)
• Stryker Launches Pangea Plating System In Europe Two Years After US Debut (MedTech Insight)
• QT Imaging CEO: AI Cannot Recover What Mammography Never Captured (MedTech Insight)

Food & Nutrition

• How the food and beverage industry is rethinking manufacturing investments (Food Dive)
• FDA to reassess safety of ‘yoga mat’ chemical in food (Food Dive)
• Ebola Outbreak Drives Medical Device Makers to Mobilize PCR Tests and Blood-Filtration Technology (MedTech Insight)

Government, Regulatory & Legal

• What do early data from Utah’s Doctronic AI pilot show? (STAT)
• The innovation trap: How pharma weaponizes a word to extend monopolies (STAT)
• Can AI do scientific research? Billions are pouring in to find out (Endpoints)

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.