Recon: FDA may rethink shortage listing for Eli Lilly’s tirzepatide; Pfizer nabs FDA approval for injectable Hympavzi for hemophilia
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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.
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