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April 10, 2025
by Jason Scott

Recon: FDA allowing some reviewers to telework; Trump threatens tariffs on prescription drugs

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

In Focus: US
  • The trade war hits pause, but the biotech doom loop carries on (STAT)
  • FDA reverses course on telework after layoffs and resignations threaten basic operations (Associated Press)
  • Biotech CEOs to Cassidy: We're already seeing the effects of FDA's staff cuts (Endpoints)
  • Medtech Looks For Relief As Trump Hits Pause On Most Tariffs (MedTech Insight)
  • Prescription drugs become a target in Trump's trade war (Reuters)
  • Trump administration plans to remove all members of HIV advisory council (Reuters)
  • US measles battle hindered by confusion over health secretary response (Reuters)
In Focus: International                                                                                                       
  • DHL pours €2B into healthcare logistics; OXB revenues on the rise (Endpoints)
  • EU Harmonized Standards Continue To Trickle In Under MDR (MedTech Insight)
  • Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement (MedTech Insight)
  • Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape (Pink Sheet)
Pharma & Biotech
  • Gilead is urged to rework licensing deals for groundbreaking HIV prevention drug (STAT)
  • Alzheon’s amyloid-targeting pill fails another Phase 3 study in Alzheimer’s (Endpoints)
  • J&J, argenx keep rolling out myasthenia gravis data, plus more from #AAN25 (Endpoints)
  • PacBio to cut jobs, lower spending over NIH funding cuts and tariffs (Reuters)
  • Tempest seeks strategic alternatives to fund Phase 3 liver cancer trial (Endpoints)
  • Exclusive: Cardiometabolic biotech gets $57.5M Series B, with help from Cytokinetics (Endpoints)
  • Keros Therapeutics adopts poison pill as it explores options, including sale (Reuters)
Medtech
  • AI agents in health care: Everything you need to know, but didn’t know how to ask (STAT)
  • Therapy AI chatbot shows promising results: study (Endpoints)
  • Teleflex to close Minnesota facility, cut 101 employees (MedTech Dive)
  • AI scribe technology lets me focus on my patients, not a screen (STAT)
  • Kandu Health merges with BCI company Neurolutions (MedTech Dive)
  • ‘Preparing For Regulatory Milestones, Commercial Launch’ Are Priorities, Says New Freenome CEO Aaron Elliott (MedTech Insight)
Food & Nutrition
  • The wellness industry is killing animals, spreading disease, and fueling the next pandemic (STAT)
  • Debate over soda, candy bans shows how MAHA is scrambling old alliances (STAT)
  • Tariffs are the latest test of beleaguered US consumers (Food Dive)
  • Using RASFF Data, Researchers Develop Integrated AI Framework for Improved Food Safety Risk Assessment (Food Safety)
Government, Regulatory & Legal
  • The National Cancer Institute’s Investigational New Drug program is imperative for public good (STAT)
  • US NIH scientists barred from attending conferences on their own time and dime (Reuters)
  • National public health group calls for RFK Jr. to resign, citing ‘complete disregard for science’ (STAT)
  • NIH cancels funding for landmark diabetes study at a time of focus on chronic disease (STAT)
  • On an RFK Jr. road show, MAHA goals take precedence. Measles prevention less so (STAT)
  • USDA to lose bird flu response employees, source says (Reuters)
  • More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind (FDA Law Blog)
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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