Recon: Metsera plunges after accepting Pfizer’s $10B offer; Eli Lilly partners with MeiraGTx's for eye disease gene therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Is the White House’s deal with pharma on GLP-1 drugs a game changer? (STAT)
- Fate of ACA subsidies still clouded after deal to reopen the government (STAT)
- US FDA Begins ‘Competitive Search’ For New Drugs Center Director (Pink Sheet)
- Metsera falls after accepting up to $10 billion offer from Pfizer (Reuters) (Endpoints)
- Eli Lilly signs deal for MeiraGTx's gene therapy for severe eye disease (Reuters) (Endpoints)
- PDUFA VIII: FDA Pilot Programs, Workforce Challenges Could Shape Renewal Debate (Pink Sheet)
- Makary And Oz Tout Successes At Their Respective Agencies, Say They Are Breaking Down Walls (MedTech Insight)
- Novartis opens new plant in California to make cancer drugs (Reuters)
- Canada loses measles elimination status — as does the entire Americas region (STAT)
- German online drug retailer Redcare Pharmacy names Hendrik Krampe as CFO (Reuters)
- Germany's Siemens to set out plan for $41 billion Healthineers stake (Reuters)
- India Sets Sights On ‘First-In-World’ Medtech Innovation (MedTech Insight)
- Novo Nordisk, Emcure to launch weight-loss drug under new brand in India (Reuters)
- Under Pressure: How To Safeguard The EU Responsible Person (MedTech Insight)
- Weight-loss drug developers line up to tap lucrative market as competition heats up (Reuters)
- Roche reports two Phase 3 wins for its BTK inhibitor in multiple sclerosis (Endpoints)
- Merck’s pill to reduce cholesterol on top of statins matches results from injectables (STAT)
- How Regulatory Horizon Scanning Works In The EU, UK & Switzerland (Pink Sheet)
- US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says (Pink Sheet)
- Ex-Lilly Diabetes leaders hunt for new obesity drugs at VC firm aimed at 'advancing the science' (Endpoints)
- Catalent lays off more gene therapy workers in Baltimore (Endpoints)
- Cogent soars on back of Phase 3 success in stromal tumors (Endpoints)
- AnaptysBio reports Phase 2 fail in ulcerative colitis; Lyell's CAR-T licensing deal (Endpoints)
- CRISPR Therapeutics’ gene editing therapy halves cholesterol and triglycerides in early trial (Endpoints)
- Ionis claims curative potential for Tryngolza in severe triglyceride disease (Endpoints)
- Microsoft launches 'superintelligence' team targeting medical diagnosis to start (Reuters)
- Exclusive: AI biotech Iambic raises $100M, expects three drugs in clinic in 2026 (Endpoints)
- MMI tackles Alzheimer’s; SS Innovations advances telesurgery (MedTech Dive)
- Synchron raises $200M to prepare for brain computer interface launch (MedTech Dive)
- Olympus to cut 2,000 jobs in endoscopy reorganization (MedTech Dive)
- Does coffee mix with AFib, and other new data from heart meeting (STAT)
- At AHA meeting, CRISPR data gleamed but ‘food as medicine’ spoke to the now (STAT)
- It’s time to fundamentally rethink how America pays for health care (STAT)
- Trump renews a Republican battle cry: Repeal Obamacare (STAT)
- Ninth Circuit Sends USDA’s Agricultural Marketing Service (“AMS”) Back to Drawing Board on Some Aspects of the BE Labeling Rule (FDA Law Blog)
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