Recon: FDA staff reviewing Musk’s Neuralink among those fired; Bavarian Nordic nabs FDA approval for chikungunya vaccine
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Exclusive: FDA staff reviewing Musk’s Neuralink were included in DOGE employee firings, sources say (Reuters)
- Leader of FDA food division resigns (NBC News)
- Biogen partners with Stoke Therapeutics on drug for severe epilepsy (STAT)
- Hikma takes Amarin's 'skinny label' fight to the Supreme Court (Endpoints)
- Bavarian Nordic wins FDA OK for chikungunya vaccine in challenge to Valneva (Endpoints)
- FDA approves Ono’s rare joint tumor drug, setting up battle with Daiichi (Endpoints)
- J&J begins crucial battle over $10 billion baby powder settlement (Reuters)
- What to Expect When you are Expecting…a Government Shutdown (FDA Law Blog)
- South African scientists were testing a promising HIV vaccine. Then came Trump’s aid cuts (Reuters)
- Canada reports outbreak of H5N5 bird flu on backyard farm (Reuters)
- French bird flu vaccine campaign helps poultry output recover, producers say (Reuters)
- Digostics At-Home Type 1 Diabetes Test Trialed In Children For Routine UK NHS Use (MedTech Insight)
- Korea ‘Guide’ Program To Speed Select Innovative Products To Market (Pink Sheet)
- EU HTA Regulation: Joint Scientific Consultations Are An ‘Important Strategic Opportunity’ (Pink Sheet)
- Novo Nordisk alleges fraud after $1.3 billion deal to buy hypertension drug from KBP Biosciences (Reuters)
- Could SSRIs protect against infections? A mouse study has hints (STAT)
- After research pivot, Biogen beefs up pipeline with Stoke's late-stage Dravet candidate (Endpoints)
- Septerna ends Phase 1 trial for hypoparathyroidism drug; Sanofi’s Merilog is approved (Endpoints)
- Pain biotech Latigo eyes up to $150M raise following Vertex's landmark FDA nod (Endpoints)
- French biotech’s topical pain treatment fails Phase 2 study with overperforming placebo (Endpoints)
- Exclusive: Lux leads $25M Series A in a Lithuanian startup plotting US expansion (Endpoints)
- Medtronic nears FDA submission for Hugo robot (MedtechDive)
- XRHealth makes another acquisition, aiming to be a leading virtual provider using VR (STAT)
- Exclusive: Subsense launches with $17M to build a noninvasive brain computer interface (Endpoints)
- Exclusive: Atomwise, a once high-flying AI startup, taps biotech vet as CEO to lead pared-down company (Endpoints)
- Medtronic's diabetes device sales drive profit beat but surgical unit lags (Reuters)
- J&J resumes PFA cases, but analysts warn safety may hamper rollout (MedTech Dive)
- Mitigating tariffs: EY’s Lynlee Brown discusses strategies for medtech (MedTech Dive)
- Upcoming Medtech Guidance: 35 New Or Revised Documents Due In 2025 (MedTech Insight)
- The lasting human impact of Trump funding freeze: An 86-year-old’s ride to dialysis now feels tenuous (STAT)
- At premier science gathering, ‘anger, uncertainty, and anxiety’ about the future of research under Trump (STAT)
- Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze (Pink Sheet)
- What J&J Is Trying to Achieve in Bankruptcy Court (Bloomberg)
- Global Fund Seeks $18 Billion as US Retreats From Public Health (Bloomberg)
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