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)
- 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)
- 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)
- 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)
- 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)
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