Recon: HHS plans to cut 10,000 jobs across department; FDA having difficulty meeting product reviews after layoffs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- RFK Jr. Plans 10,000 Job Cuts in Major Restructuring of Health Department (WSJ) (STAT)
- Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs (Reuters)
- Vaccine critic’s apparent selection to head HHS autism study shocks experts (STAT)
- US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome (Reuters)
- AbbVie, J&J to add proprietary data to AI protein model in bid to accelerate drug discovery (STAT)
- Republicans’ plan to cut government spending is hitting a major snag: Medicaid (STAT)
- Trump turbulence stalls large pharma and biotech deals, bankers say (Reuters)
- U.S. Prosecutors Probe Tip About Timing of Pfizer Vaccine (WSJ)
- Targeting FDA user fees would leave agency gutted, experts say (Roll Call)
- GSK taps into UK health data for dementia study (Pharmaphorum)
- UK's Starmer heads for test of health strategy as Reform gains ground (Reuters)
- KKR nears deal to buy Japanese medical gear maker Topcon, sources say (Reuters)
- This Canadian company’s AI tool could help drugmakers cut risk in late-stage cancer trials (STAT)
- Bayer acquires rights in Puhe BioPharma cancer drug candidate (Reuters)
- Lilly adds Alzheimer's to online offerings (Reuters)
- Merck plans to launch US subcutaneous version of Keytruda on October 1 (Reuters)
- Impatient about cell and gene therapy? Progress in biotech is not always linear (STAT)
- Burst PIPEs? So-so returns for biotech’s once-buzzy financing vehicle (STAT)
- Soleno Therapeutics’ ‘life-changing’ rare-disease drug approved (STAT)
- Study suggests mRNA vaccine could make humans resistant to ticks that transmit Lyme bacteria (STAT)
- Wave to submit Duchenne drug for approval after Phase 2 success (STAT)
- First gene-edited pig liver transplanted into a brain-dead person (STAT)
- Galatea Bio gets $25M to map genetic diversity of 10 million people, help pharma create new medicines (Endpoints)
- Candel to focus on non-squamous lung cancer following new survival data (Endpoints)
- Nkarta to lay off 34% of staff; Savara’s debt financing deal (Endpoints)
- Why Miga Health's co-founders decided to quit building (Endpoints)
- Aurion CEO is out as Alcon takes majority stake in cell therapy startup (Endpoints)
- New tests for Alzheimer’s and cancer get FDA’s ‘breakthrough’ status (STAT)
- Bausch + Lomb recalls some of its implantable eye lenses (Reuters)
- Recent pharma-telehealth partnerships feel ‘black boxy,’ and why that’s problematic (STAT)
- Financial returns and efficiency of AI scribes remain unclear, report finds (Endpoints)
- Research Finds Benefit From DME Suppliers For People Living With Diabetes (MedTech Insight)
- Dexcom’s FDA warning letter reveals unauthorized changes to sensors (MedTech Dive)
- Adios to Synthetic Colors in Food? (FDA Law Blog)
- FDA Releases Updated Food Allergen Guidance in Searchable Format; Removes Coconut From Major Food Allergens (Food Safety)
- On NIH director’s first day, the agency tackles one of his priorities — ending ‘censorship’ in science (STAT)
- Tara Schwetz, who oversaw creation of ARPA-H, placed on leave by NIH (STAT)
- Trump administration says it will pull back billions in Covid funding from local health departments (STAT)
- US pulls back $12 billion in funding to state health departments (Reuters)
- Trump healthcare price transparency order may not bring intended relief to patients (Reuters)
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