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February 18, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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
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.
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