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June 13, 2024
by Jason Scott

Recon: Supreme Court rejects lawsuit challenging abortion pill deliveries; Pfizer’s Duchenne muscular dystrophy gene therapy falters in late-stage study

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

In Focus: US
  • Supreme Court unanimously rejects challenge to mailed abortion pills (STAT) (Reuters)
  • Abortion pill still under legal threat despite US Supreme Court ruling (Reuters)
  • Was the FDA Panel Right to Recommend Against MDMA Approval? (Medpage Today)
  • Pfizer’s gene therapy for Duchenne muscular dystrophy fails in Phase 3 trial (STAT)
  • Biden and Trump are fighting to claim credit for $35 insulin. It was actually a pharma giant’s idea (STAT)
  • Exclusive: Former Merck scientists raise $85M to map and drug protein interactions in cancer and autoimmune disease (Endpoints)
  • J&J returns bispecific T cell engager to Xencor, reducing scope of partnership (Endpoints)
  • US Southern Baptists condemn IVF procedure (Reuters)
  • U.S. healthcare spending rises to $4.8 trillion in 2023, outpacing GDP (Reuters)
In Focus: International
  • Alchem accused of pharma price fixing by EU watchdog (Reuters)
  • Global health leader critiques ‘ineptitude’ of U.S. response to bird flu outbreak among cows (STAT)
  • Europe is set to shake up the way it assesses new medicines. Gene therapy makers are worried (STAT)
  • EU Regulators Clarify How ‘Super-Grouping’ Under New Variations Rules Will Work (Pink Sheet)
  • Ireland Should Look To UK & Denmark To Raise Its Clinical Trial Aspirations (Pink Sheet)
Pharma & Biotech
  • Eli Lilly’s Alzheimer’s candidate, Bob Langer’s new startup, and other biotech news you need to know (STAT)
  • With Avidity and Pfizer, gene therapy enters a phase (STAT)
  • Will Geron be acquired? The long-short view (STAT)
  • 'Speed is everything': Versant-backed immunology startup raises $125M with plans for quick data (Endpoints)
  • AbbVie banks on second-gen TL1A program, licensing antibody from FutureGen (Endpoints)
  • UroGen touts long duration of response for its bladder cancer chemotherapy gel (Endpoints)
  • Avidity’s $300M offering; Rapport raises $174M (Endpoints)
  • Surprise flop for Cara’s oral pruritis drug forces company to cut its last R&D program (Endpoints)
  • Barinthus Bio to lay off 25% of its workforce and focus on just two programs (Endpoints)
Medtech
  • Masimo embroiled in dual DOJ, SEC probes (MedTech Dive)
  • Medline pulls thousands of endotracheal tubes due to risk of airway blockage (MedTech Dive)
  • Philips launches stent system to restore blood flow in blocked veins (MedTech Dive)
  • Kardium raises $104M to develop pulsed field ablation system (MedTech Dive)
Government, Regulatory & Legal
  • Melinda French Gates, going solo, aims to influence reproductive rights in the U.S. (STAT)
  • Is $13B Devoted Health succeeding where other insurance upstarts have failed? (Endpoints)
  • Elevance exec says Medicaid attrition has changed mix of members (Reuters)
  • Guardant sues Tempus AI over DNA-testing patents (Reuters)
  • Probiotics maker Seed Health explores $1 billion sale, sources say (Reuters)
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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