Recon: Neumora abandons depression drug after Phase 3 misses; FDA signs off on Colorado’s plan to import drugs from Canada
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA approves Colorado’s plan to import cheaper drugs from Canada (STAT)
- CMS creates office dedicated to health technology (MedTech Dive)
- Orange You Glad You Used the Right Form? (FDA Law Blog)
- BsUFA IV: Industry Questions US FDA’s ‘Buy One, Get One Half Off’ Application Fee Proposal (Pink Sheet)
- Baby formula maker Nara issues US-wide recall after FDA, CDC flag infant botulism cases (Reuters)
- Ebola risk for World Cup is 'extremely low', but US is ready, experts say (Reuters)
In Focus: International
- WHO director-general is profoundly concerned after visit to Ebola outbreak area (STAT)
- A key European clinical trial registry lacks complete and timely results, an analysis finds (STAT)
- Drugmakers will not be exempt from cost cuts, says German health minister (Reuters)
- German government to abandon variable drug discounting plans, source tells Reuters (Reuters)
- Global drugmakers invest billions to boost US presence (Reuters)
- Australia's Sigma Healthcare jumps after dropping pursuit of Boots (Reuters)
- Congo says 782 Ebola cases confirmed, two new health zones affected (Reuters)
Pharma & Biotech
- Amid confusion over Pfizer’s emergency penicillin program, newborn is diagnosed with preventable syphilis (STAT)
- FDA approves Sanofi diabetes drug for children with stage 3 diabetes (STAT)
- Neumora scraps depression drug development after repeated trial failures (Reuters)
- Elicio shares tumble after pancreatic cancer therapy misses mid-stage study goal (Reuters)
- Lundbeck drug candidate shows promise in Cushing's disease trial (Reuters)
- Lilly puts its stamp at EHA with Jaypirca combo data in CLL, first clinical data from Ajax buyout (Endpoints)
- German biotech nets $50M to advance two depression drugs, including Spravato challenger (Endpoints)
Medtech
- Medtronic closes Scientia Vascular takeover, continuing M&A streak (MedTech Dive)
- Penumbra’s FDA nod for clot removal tech a win for Boston Scientific (MedTech Dive)
- UK’s MHRA To Pilot Up To Five AI Drug Safety Tools Via Regulatory Sandbox (MedTech Insight)
- CSL Vifor To Inform EU Healthcare Professionals About Liver Injury Risk With Tavneos (MedTech Insight)
Food & Nutrition
- One California politician’s unexpected crusade against ultra-processed food (STAT)
- Nestlé USA removes artificial colors in all food and beverages (Food Dive)
Government, Regulatory & Legal
- Covid vaccination cut risk of adverse heart events, large study finds (STAT)
- As states follow Trump’s Medicaid fraud playbook, people with disabilities struggle to find care (STAT)
- Private jets, wildfire relief and $23,000 internet: The 2025 oddities of biopharma executive pay (Endpoints)
- The New AI Trust Moat: How Medical Societies Are Becoming Gatekeepers Of Clinical Intelligence (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.
