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27th March 2025
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.