Recon: FDA may rethink shortage listing for Eli Lilly’s tirzepatide; Pfizer nabs FDA approval for injectable Hympavzi for hemophilia

• In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list (STAT)
• Catalent sells New Jersey plant to Belgian CDMO, plans moving HQ elsewhere (Endpoints)
• Pfizer gets an FDA win in hemophilia after a rough week (Endpoints)
• Stealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare disease drug (Endpoints)
• Teva Inks $450m Deals Over US Kickback Claims, Including Alleged Copay Violations (Pink Sheet)

• WHO approves Bavarian Nordic's mpox vaccine for adolescents (Reuters)
• Bayer applies for third indication of Nubeqa in EU (Reuters)
• Denmark's Lundbeck bets on epilepsy drug in $2.6 bln Longboard deal (Reuters)
• France seeks job guarantees from Sanofi over Doliprane painkiller production (Reuters)
• Has Competition Reassurance Helped Counter Combination Woes In The UK? (Pink Sheet)

• Chasing CAR-T, biotech finds its next gold rush in autoimmune disease (STAT)
• Lundbeck to buy neurology-focused Longboard Pharmaceuticals in $2.6 billion deal (STAT)
• SalioGen Therapeutics hit by layoffs, as gene-editing biotechs continue to struggle (STAT)
• Mark Pruzanski gets another shot at MASH, joining as chair of Inventiva as it gets ‘much needed funding’ (Endpoints)
• Transgene shares dip as therapeutic cancer vaccine disappoints in Phase 2 trial (Endpoints)
• Turnstone rejigs staff and exec team, eases preclinical work as cash runs low (Endpoints)
• Evonik telegraphs another 260 layoffs amid multiyear reorganization (Fierce Pharma)

• Digital health deal count declines in Q3, but check sizes stabilize: Rock Health (MedTech Dive)
• Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages (MedTech Dive)
• Abbott enrolls pivotal PFA study 4 months ahead of schedule (MedTech Dive)
• Solventum names Egeland as chief medical officer (MedTech Dive)
• Get It Done In 100 Days: European Commission Told To Deliver On Revising Device Regulation (MedTech Insight)
• Cybersecurity And LDT Enforcement Top FDA’s Guidance Priorities for 2025 (MedTech Insight)
• College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule (MedTech Insight)

• Medical journal peer reviewers are paid millions by industry, study finds (STAT)
• Harris’ Medicare at home plan doesn’t go nearly far enough (STAT)
• Nobel-winning AI was built on open science. Will the quest for profits quash collaboration? (STAT)
• Medical journal peer reviewers are paid millions by industry, study finds (STAT)
• Replace Or Repair? Cardiologist, TRiCares CEO On Changes In Tricuspid Valve Intervention (MedTech Insight)
• Animal Testing Alternatives Need Central Office At US FDA, Science Board (Pink Sheet)