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May 13, 2024
by Jason Scott

Recon: Sanofi eyes $1.1B investment in French manufacturing sites; Shionogi COVID treatment misses endpoint in Phase 3 trial

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

In Focus: US
  • Congress: Close Medicare’s dangerous gaps in coverage for addiction treatment (STAT)
  • FDA is criticized for taking a ‘ministerial’ role in sorting out some pharma patents (STAT)
  • False Claims Act trends and expected enforcement priorities for 2024 (Reuters)
  • J&J to exit spinoff Kenvue with latest stake sale (Reuters)
  • US reclassification could drive fresh research funding into pot sector (Reuters)
In Focus: International
  • Sanofi pledges new 1 bln euros worth of investments in French production sites (Reuters)
  • Japan's Shionogi says COVID treatment did not meet endpoint in late-stage trial (Reuters)
  • Sandoz leaves U.K. trade group over dispute about promoting a biosimilar for multiple sclerosis (STAT)
  • Updated: France draws €2B+ research, manufacturing investment from Sanofi, Pfizer, AstraZeneca, GSK (Endpoints)
  • France secures jobs, investments from Amazon, Pfizer and Morgan Stanley (Reuters)
  • Edwards Lifesciences hit with Meril's EU antitrust complaint (Reuters)
  • Denmark faces Wegovy shortage due to rising demand (Reuters)
Pharma & Biotech
  • We now know Tome’s gene editing target (STAT)
  • Late-stage results set up Cytokinetics heart drug to compete with Bristol (STAT)
  • Cytokinetics lifts curtain on Phase 3 aficamten data, commercial launch prep underway (Endpoints)
  • CRISPR edits fail to cure HIV patients in early test (STAT)
  • Cardurion touts Ph2 data for PDE9 inhibitor in heart failure, plans for two more trials (Endpoints)
  • Deciphera had another bidder before Ono deal; Bristol Myers reports Ph3 fail in lung cancer (Endpoints)
  • Takeda bets $100M upfront on AC Immune's anti-amyloid Alzheimer's vaccine (Endpoints)
  • Merck winds down Phase 3 TIGIT/PD-1 combo study due to safety-related dropouts (Endpoints)
  • Carolyn Bertozzi-founded Lycia Therapeutics raises $106M to enter the clinic (Endpoints)
  • NewVale unveils $167M fund to back pharma service providers and 'old ideas that are working' (Endpoints)
  • 'Attack JAK': Ajax secures $95M to test new JAK2 inhibitor after industry's string of myelofibrosis deals (Endpoints)
  • Sanofi buys ex-US rights to Fulcrum's Phase 3 rare neuromuscular drug (Endpoints)
Medtech
  • Can AI build custom ‘n-of-1’ drugs faster? Maybe not yet, new case study suggests (STAT)
  • FDA targets health inequality by improving at-home devices (MedTech Dive)
  • J&J’s Megadyne discontinues pediatric electrode pad after burn reports (MedTech Dive)
  • Masimo offers Politan a concession to avoid second proxy fight (MedTech Dive)
Government, Regulatory & Legal
  • After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries (STAT)
  • A dose of reality on adult vaccinations (STAT)
  • CDC launching wastewater dashboard to track bird flu virus spread (STAT)
  • First recipient of kidney transplant from genetically engineered pig has died, family says (STAT)
  • Pharmacy exec sentenced in Michigan over deadly 2012 meningitis outbreak (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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