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April 22, 2025
by Jason Scott

Recon: FDA announces three leadership hires; Roche to invest $50B in US to avoid tariffs

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • NIH director calls Trump’s anti-DEI orders ‘misunderstood,’ downplays reorganization plans (STAT)
  • FDA Commissioner Marty Makary announces three new hires in leadership team (STAT)
  • Trump looking at cutting US drug prices to international levels, sources say (Reuters)
  • Drugmakers stockpile inventory in the US, seeking to get ahead of Trump tariffs (Endpoints)
  • Reports Document FDA Review Delays: What Drugmakers Should Know Now (FDA Law Blog)
In Focus: International                                                                                                       
  • Malnutrition treatments halted in Ethiopia due to underfunding, WFP says (Reuters)
  • Getinge says tariffs will not change established supply chains (Reuters)
  • ICH Modernizes Stability Testing Guideline (Pink Sheet)
  • EU Biosimilar Filings, Opinions And Approvals (Pink Sheet)
  • Israel steps up Gaza strikes; polio vaccination halted by blockade (Reuters
Pharma & Biotech
  • Roche to invest $50 billion in US to avoid Trump tariffs, create 12,000 jobs (Reuters)
  • Regeneron to invest over $3 billion to boost US manufacturing (Reuters)
  • Billionaire Carl Icahn builds 34% economic interest in Bausch Health (Reuters)
  • Danaher beats quarterly profit, expects incremental costs from US tariffs (Reuters)
  • Gilead says Trodelvy-Keytruda combo effective for aggressive breast cancer type (Reuters)
  • Exclusive: George Church startup will study long-lived animals, humans to find life-extending genes (Endpoints)
  • As the XBI suffers, Q1 shows a few comforting signs of underlying stability (Endpoints)
  • Preventive health startup Superpower raises $30M (Endpoints)
  • Leo pads case for chronic hand eczema nod with survey showing overwhelming effects on patient lives (Fierce Pharma)
Medtech
  • Quest beats quarterly profit estimates on strong demand for diagnostic tests (Reuters)
  • FDA issues early alert for BD catheters due to leaks (MedTech Dive)
  • Ceribell wins FDA nod for algorithm to detect pediatric seizures (MedTech Dive)
  • Italy’s IMQ Designated As 15th Notified Body For IVDs (MedTech Insight)
  • Migraine Relief Without A Pill: Click’s FDA Cleared CT-132 Turns Smartphone Into Therapy Tool (MedTech Insight)
Food & Nutrition
  • US FDA suspends milk quality tests amid workforce cuts (Reuters)
  • Short-term diet trials are designed to fail (STAT)
  • Researchers Develop Nanocage-Based Filter That Removes 90 Percent of PFAS From Groundwater (Food Safety)
Government, Regulatory & Legal
  • UnitedHealth discloses $1.7 million in security spending after slaying of top exec (STAT)
  • Employers should continue waiving preventive care out-of-pocket costs regardless of how Supreme Court rules (STAT)
  • Alvogen unit appeals court loss shielding Bausch Health's IBS drug from generics (Endpoints)
  • US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines (Pink Sheet)
  • Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’ (Pink Sheet)
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.
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