Recon: Tidmarsh resigns as CDER chief amid inquiry, lawsuit; Kimberly-Clark to buy Tylenol maker Kenvue for $40B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Pfizer files second lawsuit against Novo Nordisk, Metsera in battle over obesity startup (STAT)
- Breaking: Metsera calls Pfizer threats 'nonsense' as rift widens between companies (Endpoints)
- FDA’s top drug regulator resigns amid investigation (STAT) (NYTimes)
- AstraZeneca, Lilly, Merck contribute $120M to support manufacturing talent in Virginia (Endpoints)
- Kimberly-Clark bets $40 billion for Kenvue despite Tylenol controversy (Reuters) (Endpoints)
- Antibiotics Must Cost More Than M&Ms, Sandoz Tells Governments (Bloomberg)
- Lilly earmarks $3B for new European obesity pill factory (Endpoints) (Reuters)
- UK regulators look to speed up how rare disease therapies reach the market (Endpoints)
- UK MHRA Deepens AI Regulatory Expertise As Airlock Moves Into Phase 2 (MedTech Insight)
- Amazon’s Layoffs Show How AI Is Coming for India (Bloomberg)
- Last Call For £6M UK Funding Open To AMR Innovators Worldwide (Pink Sheet)
- UniQure’s FDA submission for its Huntington’s disease therapy thrown into question (STAT)
- Caribou’s off-the-shelf CAR-T therapy shows promise in lymphoma study (STAT)
- Vertex, CRISPR say Casgevy shows promise in younger children (Endpoints)
- TScan to cut a third of its staff; Iovance advances Amtagvi in lung cancer (Endpoints)
- Lilly’s Jaypirca matches Imbruvica in Phase 3 early blood cancer trial (Endpoints)
- Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024? (Pink Sheet)
- Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval (Pink Sheet)
- AI for medical coding is helping this primary care clinic open a dozen more locations (STAT)
- A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway (STAT)
- Edwards CFO Scott Ullem to exit post (MedTech Dive)
- Olympus further clarifies device use after serious injuries and death (MedTech Dive)
- Dexcom execs say company has fixed G7 quality problems (MedTech Dive)
- Agilent selects Adam Elinoff as CFO (MedTech Dive)
- Delays and uncertainty around SNAP; health care subsidies expire (STAT)
- Food companies can now certify their products as free from ultraprocessed ingredients (Food Dive)
- In Texas, the nation’s MAHA capital, many are frustrated with the status quo in health care (STAT)
- The big flaw in Big Pharma’s ‘patient advocacy’ (STAT)
- The Americas, led by Canada, is on the brink of losing measles-elimination status (STAT)
- Medicare finalizes rule to lower payments for surgeries (STAT)
- States reject Dr. Oz’s claims of Medicaid spending on undocumented immigrants (STAT)
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