Recon: Novo’s Wegovy nabs FDA approval for higher dose under CNPV program; FDA authorizes J&J’s oral psoriasis drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- National survey of NIH-funded researchers shows precarious state of U.S. science — ‘This is like the Titanic’ (STAT)
- US FDA approves higher dose of Wegovy (Reuters)
- Senate Democrats lay out plans to overhaul health insurance after setbacks under Trump (STAT)
- There is a successor to 340B lurking on the horizon (STAT)
- As Trump administration cracks down on health care fraud, people with disabilities feel singled out (STAT)
- Four major drugmakers will face revived case over 340B prices (Endpoints)
- AstraZeneca deepens UK-China ties with cell therapy R&D hub, manufacturing plans (Endpoints)
- House lawmakers signal willingness to counter China’s biotech gains (Endpoints)
- UK health official says too soon to declare Kent meningitis outbreak contained (Reuters)
- Amplifon Buys GN Hearing For €2.3Bn, Taking Aim At Sonova And Demant (MedTech Insight)
- Injuries, Death, Linked To Intuitive Surgical Stapler Used With Da Vinci Robotic System (MedTech Insight)
- Eli Lilly’s ‘triple-G’ drug leads to significant blood sugar, weight reductions in diabetes trial (STAT)
- Clearing tumors in mice, Azalea Therapeutics advances dream of in vivo CAR-T therapy (STAT)
- How ARPA-H is developing FDA-authorized AI agents, tested in clinical trials (STAT)
- A Huntington’s researcher on the UniQure-FDA fray (STAT)
- Pfizer seeks earlier use of Talzenna in prostate cancer with Phase 3 win (Endpoints)
- Collegium is acquiring Corium's approved ADHD drug for $650M (Endpoints)
- Washington’s Medicaid program will pay for ElliQ, an AI robot for loneliness (Endpoints)
- Updated: Lilly’s triple-G comparable with Mounjaro, first Phase 3 diabetes data suggest (Endpoints)
- Exclusive: Congruence raises $40M, enters clinic with lead obesity drug (Endpoints)
- Exclusive: Specialty care network company Lantern raises $30M (Endpoints)
- US FDA approves J&J's oral psoriasis pill (Reuters)
- After Alfasigma's GSK licensing deal, Lynavoy picks up FDA nod in rare liver disease (Fierce Pharma)
- Intuitive Surgical recalls stapler reloads over issue linked to patient death (MedTech Dive)
- MiniMed gets FDA nod for smaller insulin pump (MedTech Dive)
- JenaValve snags FDA approval in aortic regurgitation (MedTech Dive)
- Cognito Shows Off More Positive Data For Device-Based Alzheimer’s Treatment (MedTech Insight)
- JenaValve’s Trilogy Becomes First FDA-Approved TAVR Treatment For Aortic Regurgitation (MedTech Insight)
- ECDC renews Cape Verde warning as illnesses continue (Food Safety News)
- FDA continues investigation of outbreaks (Food Safety News)
- HHS watchdog slams nursing homes’ antipsychotic drug use and schizophrenia diagnoses (STAT)
- A Maryland legislator wants pharma and patient groups to disclose ties to disease awareness campaigns (STAT)
- How a Texas couple is getting rich off out-of-network medical bills (STAT)
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