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March 26, 2024
by Jason Scott

Recon: Supreme Court seems skeptical of mifepristone challenge; Lawmakers query FDA on Neuralink inspection

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • US Supreme Court appears skeptical of challenge to abortion pill access (Reuters)
  • Johnson & Johnson considers deal for shockwave medical (WSJ)
  • Amgen sues Colorado over its prescription drug affordability board (STAT)
  • Vertex Pharmaceuticals is considering relocating its headquarters (STAT)
  • Exclusive: US lawmaker seeks answers on FDA inspection of Musk's Neuralink (Reuters)
  • During the pandemic, were great vaccines bad business? A company-by-company review (STAT)
  • Alexion adds fourth indication for C5 inhibitor Ultomiris in rare autoimmune disorder (Endpoints)
  • Regeneron's blood cancer therapy faces setback as FDA raises trial concerns (Reuters)
  • Regeneron Oncology Setback Delivered By US FDA Crackdown On Accelerated Approval (Pink Sheet)
  • FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts (FDA Law Blog)
In Focus: International
  • How expanded methadone access helped Switzerland defuse its drug crisis (STAT)
  • Brazil aims to manufacture its own cell therapies — at a fraction of the current cost (Endpoints)
  • New HTA Evidence Guidelines In EU Could Spell Trouble For Advanced Therapy Companies (Pink Sheet)
  • EU Warns Of Life-Threatening Interactions Between Paxlovid & Some Immunosuppressants (Pink Sheet)
  • EU CHMP Opinions And MAA Updates (Pink Sheet)
Pharma & Biotech
  • Merck’s next big thing is (probably) on the way (STAT)
  • Viking Therapeutics to move its oral obesity drug into Phase 2 study after early success (STAT)
  • Stoke unveils new data on genetic epilepsy drug — and investors are stoked (Endpoints)
  • Edgewood's $20M Series A; Nanoscope to pursue FDA approval for eye gene therapy later this year (Endpoints)
  • Praxis touts topline data for epilepsy drug in first of four readouts (Endpoints)
  • Exclusive: Athena Countouriotis' Avenzo nabs $150M to in-license more assets (Endpoints)
  • PE firm Olympus to sell up to $235 mln stake in India's Aster DM, term sheet shows (Reuters)
  • How Pharma Firms Using AI Should Navigate Regulatory Submissions (Pink Sheet)
  • US FDA's CDER Creates Quantitative Medicine Center Of Excellence; Job Includes AI Oversight (Pink Sheet)
Medtech
  • A new report questions whether digital diabetes programs are worth the cost (Endpoints)
  • Phathom’s first campaign for acid blocker Voquezna is the latest to use telehealth to reach potential patients directly (Endpoints)
Government, Regulatory & Legal
  • Rite Aid reaches bankruptcy settlement with lenders, DOJ, McKesson (Reuters)
  • Gene therapy maker bluebird to revise financials after accounting errors (Reuters)
  • Incorporating Pharmacy Spending In Value-Based Payment Models Remains Challenging (Pink Sheet)
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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