Recon: Delaware judge allows 70,000 Zantac lawsuits to proceed; BD to buy Edwards’ critical care unit for $4.2B

• Anthony Fauci, facing GOP accusers, says debate on Covid origins has been ‘seriously distorted’ (STAT)
• US FDA advisers to consider if new COVID shots should target JN.1 variant (Reuters)
• NIH documents show how $1.6 billion long Covid initiative has failed so far to meet its goals (STAT)
• Becton Dickinson to buy Edwards patient monitoring unit for $4.2 billion (STAT)
• GSK shares tumble 9% after 70,000 Zantac lawsuits allowed to proceed (Endpoints) (Reuters)
• Novo Nordisk Should Have Studied Insulin Icodec Twice-Weekly Dosing, US Panel Says (Pink Sheet)
• PROs In Diabetes: FDA Panel Wanted Data Proving Insulin Icodec’s ‘Theoretical’ Benefits In Type 1 (Pink Sheet)
• US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer (Pink Sheet)
• Women’s Health a Focus for FDA and Biden Administration (FDA Law Blog)
• Moderna-Merck skin cancer vaccine shows survival benefit in long-term follow-up (Reuters)

• Amended International Health Regulations Give Fresh Momentum To Pandemic Treaty Talks (Pink Sheet)
• Project Orbis Led To 80% Cut In Submission Gap For Cancer Drugs In Switzerland (Pink Sheet)
• Japan Aims To Broaden RWD Use By Allowing Pseudonymised Data (Pink Sheet)
• Lykos’ MDMA Heads To AdComm With US FDA Concerns About Adverse Event Reporting (Pink Sheet)
• EU Member States Told To Step Up Efforts On Transitioning Trials To CTR (Pink Sheet)
• Chikungunya Vaccine, Hemophilia B Gene Therapy Among 14 Products On Track For EU Approval (Pink Sheet)

• Biohaven’s autoimmune drug disappoints, and other biotech news updates from the week (STAT)
• Can AstraZeneca make good on its promise? (STAT)
• Structure Therapeutics oral GLP-1 drug led to weight loss in two studies (STAT)
• Elevance PBM’s president out as customers complain of prescription chaos (STAT)
• With new results at ASCO, Enhertu once again rewrites rules of breast cancer treatment (STAT)
• Agios Pharmaceuticals' blood disorder drug succeeds in late-stage study (Reuters)
• At ASCO, AstraZeneca says its CAR-T therapy shrank solid liver tumors in early trial (STAT)
• Takeda outlines mid-stage narcolepsy data that prompted 'rapid' move into Phase 3 (Endpoints)
• After Phase 3 win, Arrowhead's RNAi chases Ionis to market entry in rare genetic disorder (Endpoints)
• Exclusive: Isotope shortage forces pause of Bristol Myers Phase 3 radiopharmaceutical trial (Endpoints)
• Caribou says partial HLA matching will improve durability of response to cell therapy (Endpoints)
• Rapport Therapeutics sets out for $122M Nasdaq debut as IPO backlog seeks fresh air (Endpoints)

• Abbott receives FDA OK for over-the-counter glucose monitor (MedTech Dive)
• Medtech venture capital investing rebounded in Q1 (MedTech Dive)
• Steris to lay off employees in restructuring (MedTech Dive)
• Surmodics agrees to $627M private equity buyout (MedTech Dive)
• Digital therapeutics firm Akili to sell for $34M (MedTech Dive)

• A short-lived Medicaid freakout sends insurers’ stocks diving (STAT)
• Waste Management adds medical-waste portfolio with $7.2 bln Stericycle deal (Reuters)