Recon: Amid regulatory shakeups, drugmakers schedule meeting with Trump next week; FDA clears GSK’s meningococcal combo jab
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA cuts hit AI division, even as Trump invests in the technology (STAT)
- Trump administration lays off FDA employees (STAT)
- Trump administration layoffs set to hit NIH are ‘devastating,’ former director Monica Bertagnolli says (STAT)
- US Health Department Layoffs Expand to Medicare, FDA (Bloomberg)
- Roche's US Biotech Unit Pulls Diversity Targets From Website (Bloomberg)
- US FDA approves GSK's combo meningococcal vaccine (Reuters)
- Moderna norovirus vaccine trial on hold by US FDA over neurological side effect (Reuters)
- Commission Led By HHS Secretary Kennedy Will Probe ‘Threats’ To Children, Including Medicines (Pink Sheet)
- Irish Exports Hit Record in 2024 on Medical, Pharma Goods (Bloomberg)
- The abrupt end of USAID-funded clinical trials is profoundly unethical (STAT)
- Fierce Pharma Asia—Astellas' investment focus; Mitsubishi Tanabe's buyout; Leqembi's 'expansion phase' (Fierce Pharma)
- New EU Approvals (Pink Sheet)
- Teva Pharm CEO calls on Trump for faster US drug approvals (Reuters)
- Exclusive: Drugmakers plan Trump meeting next week amid Washington health shakeups (Endpoints)
- Lilly’s early bladder cancer data hint at safety edge over J&J’s Balversa (Endpoints)
- Kojin Therapeutics shuts down, citing lack of investor interest and complex science (Endpoints)
- Corbus shares dip on mixed Phase 1 solid tumor data for Nectin-4 ADC (Endpoints)
- FDA approves Ono's rare tumor drug from $2.4B Deciphera buyout (Fierce Pharma)
- Inizio Evoke alums flex healthcare marketing prowess with launch of new agency (Fierce Pharma)
- Moderna shoulders $238M contract manufacturing cancellation charge in Q4 (Fierce Pharma)
- UCB's Bimzelx outpacing AbbVie's Rinvoq, Skyrizi on awareness early in psoriatic arthritis launch: survey (Fierce Pharma)
- The travel industry offers hospitals a warning about MyChart (STAT)
- Healthcare startup Abridge raises $250 million to enhance AI capabilities (Reuters)
- West Pharma loses two glucose device clients but is buoyed by its GLP-1 packaging services (Endpoints)
- Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft (FDA Law Blog)
- Boston Scientific Sets ‘New Clinical Innovation Standard’ For Pulsed Field Ablation (MedTech Insight)
- Class I Recalls Hit 15-Year High, According To Index Report From Sedgwick (MedTech Insight)
- AI Bias Page, Health Equity Discussion Paper Back On FDA Site (MedTech Insight)
- People with alcohol-use disorder drank less on Ozempic, small study shows (STAT)
- Texas measles outbreak rises to 48 cases. It’s the state’s worst in nearly 30 years (STAT)
- Bird flu found in Arizona milk suggests another spillover from birds to cows (STAT)
- STAT is backing up and monitoring CDC data in real time: See what’s changing (STAT)
- How Trump’s ‘fear factor’ is already reshaping American science (STAT)
- Trump cuts could clash with Kennedy's long to-do list (Reuters)
- US gives conditional nod to Zoetis' bird flu vaccine for poultry (Reuters)
- J&J to face pivotal hearing over its $8B talc settlement plan (Endpoints)
- ARPA-H chief is out as Trump administration cuts health agencies (Endpoints)
- US FDA Says Restored Webpages Do Not Reflect ‘Biological Reality’ (Pink Sheet)
- ARPA-H Announces Grants To Advance Rural Care (Pink Sheet)
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