Recon: J&J sued over employer liability for overpaying for drugs; Lilly terminates Verzenio Phase 3 trial for prostate cancer
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- The lone Democrat willing to weaken Medicare’s power to negotiate drug prices (STAT)
- A sweeping new lawsuit against J&J asks: Are employers liable if they overpay for drugs? (STAT)
- With subpar sales for Leqembi, Eisai delays Alzheimer’s patient goal deadline (Endpoints)
- FDA panel recommends new standards for pulse oximeters amid bias concerns (MedTech Dive)
- FDA to reclassify most high-risk IVDs, easing path to clearance (MedTech Dive)
- Lilly rides wave of weight-loss drug demand, working to expand capacity (Reuters)
- Eli Lilly reports tirzepatide MASH success during Q4 earnings (STAT)
- Novartis to buy MorphoSys for $2.9B after 20 years of creating antibodies with the German biotech (Endpoints)
- Gottlieb: FDA Would Be Subject To More White House Control Under A Second Trump Term (Pink Sheet)
- India’s Interim Budget Pushes Innovation, Green Production, HPV Vaccination (Pink Sheet)
- Canada Attacks Florida’s ‘Bad’ Bulk Importation Plan (Pink Sheet)
- EMA Steps Up Support For Creation Of African Medicines Agency (Pink Sheet)
- EU AI Act Final Text Approved By European Member States (MedTech Insight)
- Vertex still knows how to do what it does best (STAT)
- In a snapshot of its rare disease data, Ultragenyx boosts case for new surrogate biomarker (Endpoints)
- Rare disease biotech Rallybio cuts 19 staffers and sheds partnered preclinical programs (Endpoints)
- Immunome buys desmoid tumor asset; UK looks into Thermo Fisher-Olink deal; Kyverna's upsized IPO (Endpoints)
- Lilly axes PhIII trial of Verzenio in prostate cancer (Endpoints)
- Lilly's weight loss drug Zepbound generates $175M within weeks as Mounjaro sales also soar (Endpoints)
- AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires (Fierce Pharma) (Reuters)
- Real Chemistry snaps up Avant Healthcare to boost med comms offering (Fierce Pharma)
- Pfizer pumps $15M into American Cancer Society's screening-focused health equity push (Fierce Pharma)
- How Firms Are Using ICH Q12 Guideline To Reduce US FDA Oversight Of Manufacturing Changes (Pink Sheet)
- The Philips CPAP nightmare exposes shortcomings in medical device regulation (STAT)
- Philips consent decree ‘worse case scenario’ for respiratory business (MedTech Dive)
- Nanostring files for bankruptcy protection, explores possible sale (MedTech Dive)
- Livanova names J&J veteran Vladimir Makatsaria as CEO (MedTech Dive)
- Hologic wins FDA clearance for AI-enabled cervical cancer screening system (MedTech Dive)
- A Timeline Of Apple And AliveCor's Legal Battles (MedTech Insight)
- Medtech Industry Produces Evidence In Bid For Updated eIFU Rules In Multilingual EU Marketplace (MedTech Insight)
- Cardio Catch-Up: Procyrion Raises Nearly $60M; Aortix Creeps Closer To Clinic (MedTech Insight)
- Supreme Court to weigh whether Covid misinformation is protected speech (STAT)
- Let the Medicare Advantage lobbying begin (STAT)
- Cano Health’s downfall offers a warning for Medicare Advantage (STAT)
- Diabetes treatments have improperly listed patents that should be removed, analysis finds (STAT)
- GoodRx bets on working with pharmacies as prescription-drug reimbursement pressure grows (Endpoints)
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