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February 6, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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