Recon: Novavax nabs narrowed FDA approval for COVID-19 vaccine; FDA clears first blood test for Alzheimer’s
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Inside the rise of Tracy Beth Høeg, the Covid contrarian shaping FDA vaccine policy (STAT)
- Novavax wins narrowed approval for its Covid-19 shot after delay (STAT)
- Does the CDC have an acting director? (STAT)
- HHS can require approval for drugmakers to apply 340B rebate models, court rules (Endpoints)
- Deputy FDA chief mulls shaking up PDUFA reauthorization structure (Endpoints)
- Trump Tax Bill Advances After Deal for Faster Medicaid Cuts (Bloomberg)
- Bayer US head says FDA chief reassured pharma executives of timely reviews (Reuters)
- People in 70 countries are missing out on medical care amid funding cuts, says WHO (Reuters)
- Alzheimer’s Drugs Arrive in Taiwan to a Host of Questions (Bloomberg)
- Covid Test, Vaccine Maker Stocks Jump as Cases Surge in Asia (Bloomberg)
- Bringing Israeli Medical Device Candidates To The Right Partners In The US (MedTech Insight)
- Investment firm RA Capital lays off incubator staff amid industry instability, push into China (STAT)
- Regeneron to buy 23andMe out of bankruptcy for $256 million (STAT) (Reuters)
- David Liu, Sam Sternberg unveil new CRISPR tech for large gene insertion (Endpoints)
- Apnimed posts first set of Phase 3 sleep apnea results, aims for approval filing in 2026 (Endpoints)
- Ionis details late-stage data for heart drug; Armata’s promising staph infection therapy (Endpoints)
- Exclusive: CellCentric collects $120M to treat multiple myeloma with a capsule (Endpoints)
- Sarepta seeks to expand Duchenne gene therapy Elevidys use to toddlers (Endpoints)
- Eisai Shares Rise as New Alzheimer’s Test Seen Helping Sales (Bloomberg)
- FDA clears first blood test to aid Alzheimer’s diagnosis (MedTech Dive)
- EndoQuest, Virtuoso begin clinical trials for surgical robots (MedTech Dive)
- Dexcom CEO says CGMs fit MAHA agenda ‘very nicely’; Tandem preps for new products (MedTech Dive)
- Siemens Healthineers invests $150M in US, moves production from Mexico (MedTech Dive)
- Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show (MedTech Insight)
- How Structured Patient Engagement Gives Medtech Companies A Competitive Edge (MedTech Insight)
- Brazil can no longer export poultry and meat to EU due to bird flu (Reuters)
- Brazil hopes China, other countries may loosen trade bans over bird flu (Reuters)
- FDA to revisit approval of food chemicals that ‘concern consumers most’ (Food Dive)
- It’s a Bird, It’s a Plane, It’s an UPDATE on Operation Stork Speed (FDA Law Blog)
- There is no replacement (yet) for animal models in medical research (STAT)
- The end to animal testing marks the beginning of better biomedicine (STAT)
- UnitedHealth said it was too dangerous for him to be discharged. Days later, it denied his care (STAT)
- Trump is moving to terminate hundreds of federal grants across Harvard (STAT)
- Scientists are pushing to get their grants reinstated — and some are winning (STAT)
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