Recon: WHO recommends RSV antibody and vaccine during pregnancy; J&J to build $2B facility in North Carolina
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Struggle to regulate health AI, Epic’s antitrust challenges, and more AI news (STAT)
- U.S. lawmaker urges FDA to clarify drug patent listings in a key government registry (STAT)
- Five things FDA ad comm members want (STAT)
- Federal judge dismisses longstanding suit over Bristol Myers' $74B Celgene buyout (Endpoints)
- Exclusive: CVS explores options including potential break-up, sources say (Reuters) (STAT)
- CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes (FDA Law Blog)
- US FDA's Slim October User Fee Calendar Brings Some Controversy (Pink Sheet)
- A ‘Lame Duck’ Feast: December Could Be Busy For Pharma On Capitol Hill (Pink Sheet)
- J&J to invest more than $2 billion in new manufacturing facility (Reuters)
- WHO recommends maternal vaccine and antibody shot to prevent RSV in infants (Reuters)
- EU withdraws marketing authorisation for Abbvie's hepatitis C drug (Reuters)
- China, US health officials agree on more cooperation following rare talks (Reuters)
- EMA & FDA Eliminating ‘Needless Differences’ – Particularly For Rare Diseases (Pink Sheet)
- French Industry Calls For Reduction In Rebates, Proposes Savings Plan (Pink Sheet)
- UK’s ISRCTN Registry Makes It Easier To Track Clinical Trial Transparency (Pink Sheet)
- The latest obesity drug updates happening right now (STAT)
- An obesity startup wastes no time: With drugs in early testing, Metsera lines up manufacturing (STAT)
- $400 million for an obesity drug startup? A new venture is a sign of the times (STAT)
- Biohaven aims to raise $250M; Activist investor's stake in Galapagos exceeds 10% (Endpoints)
- Targeting Novartis' Scemblix, Enliven lays out case for leukemia drug in early results (Endpoints)
- Gritstone bio’s stock dips after it shares more data from failed Phase 2 colorectal cancer trial (Endpoints)
- CAMP4, preparing for IPO, announces partnership with BioMarin (Endpoints)
- 23andMe CEO says she is no longer open to outside takeover offers (Endpoints)
- Shattuck Labs cuts CD47 program and 40% of workforce as it focuses on IBD drug (Endpoints)
- CAR-T Therapies: Stakeholders Urge Rethinking Of Postmarketing Requirements And REMS (Pink Sheet)
- Q&A: Why medical AI and value-based care may be made for each other (STAT)
- Synchron Announces Positive Results From Stentrode BCI Study, Plans For Pivotal Study (MedTech Insight)
- Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding (MedTech Insight)
- Device Shortages A Matter Of National Security, Califf Says (MedTech Insight)
- Writing health AI rules: Why Micky Tripathi faces one of the toughest jobs in Washington (STAT)
- Health insurers unveil Medicare Advantage plans for 2025 (Reuters)
- Judge blocks Georgia law banning abortion after six weeks of pregnancy (Reuters)
- Amgen must face lawsuit claiming it hid $10.7 billion tax bill (Reuters)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
