Recon: HTA regulation: PICO consolidation goes well; US commission seeks research infrastructure revamp
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US negotiated Medicare prices for 15 more drugs to test cost savings promise (Reuters)
- US FDA approves Novartis' gene therapy for rare muscle disorder (Reuters)
- FDA's Pazdur questions legality of voucher program, sources say, in latest internal disagreement (Endpoints)
- Lawmakers probe FDA's new priority voucher program, cite corruption and rushed review concerns (Fierce Pharma)
- Walgreens nasal spray recalled over possible bacteria (The Hill)
In Focus: International
- China Biotech Deals Grow as Country Turns From Copycat to Innovator (Bloomberg)
- Straumann reaffirms growth targets as it braces for China dental market shift (Reuters)
- England Becomes First In Europe To Reimburse Autolus’ CAR-T Aucatzyl (Pink Sheet)
- UK Off-Patent Industry Urges Focus On Five Priorities Ahead Of Govt Budget (Pink Sheet)
- EU HTA Regulation: PICO Consolidation Going Well, Analysis Feasibility A Challenge (Pink Sheet)
- Angelini faces UK marketing watchdog's wrath after speaker blasts 'stupid' EMA (Fierce Pharma)
Pharma & Biotech
- Novo Nordisk Drug Helps Patients Lose Weight, Lower Blood Sugar in Trial (Wall Street Journal)
- Where GLP-1s Weight-Loss Drugs Fall Short for Women (Bloomberg)
- JD Weighs at Least $1 Billion Bond Sale Linked to Health Unit (Bloomberg)
- Novartis plans to cut up to 550 jobs at Swiss facility (Reuters)
- Novartis was the sole bidder in $12B deal to buy Avidity (Endpoints)
- After 5 Years, Acid-Reducer Is Back on the Market (MedPage Today)
Medtech
- Ceribell wins FDA clearance for seizure-detection algorithm in neonates (MedTech Dive)
- Okami raises $45M to commercialize vascular embolization devices (MedTech Dive)
- LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows (MedTech Insight)
- Medtech Sees Bigger Deals As Early Funding Tightens; LSI Is ‘Cautiously Optimistic’ For 2026 (MedTech Insight)
Food & Nutrition
- GLP-1 users to make up 35% of food and beverage sales by 2030: report (Food Dive)
- More than 100 babies have received treatment for botulism in relation to ByHeart formula outbreak (Food Safety News)
Government, Regulatory & Legal
- Federal biotech commission calls for retooling of scientific research infrastructure (STAT)
- Humana to Appeal Ruling Upholding Medicare Star Bonus Cuts (Bloomberg)
- UK-US drug pricing deal could come as early as this week, sources say (Endpoints)
- Pharma pros skeptical of letting AI loose on regulatory compliance submissions: survey (Fierce Pharma)
- SK Life Science Xcopri ad meets a roadblock with FDA untitled letter (Fierce Pharma)
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.
