rf-fullcolor.png

 

April 1, 2025
by Jason Scott

Recon: Drugmakers petition Trump for phased tariffs; Texas judge overturns FDA’s LDT regulation

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

In Focus: US
  • HHS starts layoffs of thousands of workers across its agencies (STAT) (Politico) (Reuters)
  • Pharma industry lobbies Trump for phased tariffs, sources say (Reuters)
  • Trump’s proposed tariffs may cause shortages of Canadian-made drugs in the U.S., analysis finds (STAT)
  • Reduce drug spending by drastically simplifying monopolies on drugs (STAT)
  • Rollout of ‘miracle’ HIV prevention drug is threatened by Trump cuts to global AIDS relief program (STAT)
  • Eli Lilly Threatens Obesity Drug Copycat Makers After Shortage (Bloomberg)
  • Updated: J&J’s third talc bankruptcy bid is stopped by Texas federal judge (Endpoints)
  • Democratic-led states sue to block Trump from $11 billion health funding cut (Reuters)
In Focus: International                                                                                                       
  • European Commission approves Pfizer's RSV vaccine for adults at increased risk of disease (Reuters)
  • England’s NICE Wants Industry Involvement In HTA Sandbox Projects (Pink Sheet)
  • Angelini Pharma still keen on deals after failed Recordati bid (Reuters)
  • Ceva Animal Health hits $10 billion valuation, eyes IPO (Reuters)
Pharma & Biotech
  • Emotional whiplash for PTC Therapeutics (STAT)
  • Trump tariffs hinder M&A and IPOs in what was supposed to be a blockbuster quarter (Reuters)
  • Big ambitions at Merck and AstraZeneca — along with a few giant pitfalls — reshape top ranks of the R&D 15 (Endpoints)
  • RNA editing startup raises $155M to bring liver and lung disease therapy into clinic (Endpoints)
  • Prazer Therapeutics raises $20M; Carisma lets go of most staff (Endpoints)
  • Lilly claims Phase 2 win for siRNA approach to mixed dyslipidemia (Endpoints)
  • Sanofi continues its bet on R&D by poaching GSK’s head of development (Endpoints)
  • Bayer eyes launch of menopause relief, heart drugs this year (Reuters)
  • Angelini Pharma still keen on deals after failed Recordati bid (Reuters)
  • Axsome to narrow focus of depression drug trial after limited success in initial run (Reuters)
Food & Nutrition
  • FAO Publishes Report on Food Safety Aspects of Precision Fermentation (Food Safety)
  • The Strategic Importance of Food Industry Conferences (Food Safety)
Medtech
  • Texas judge strikes down FDA’s plan to regulate lab-developed tests (STAT) (Endpoints)
  • Talkspace is using AI to make therapy podcasts for patients (Endpoints)
  • Becton Dickinson in talks with Thermo Fisher, Danaher to divest life sciences unit, FT reports (Reuters)
  • Bausch + Lomb recalls Envista intraocular lenses over safety risks (MedTech Dive)
  • Abbott’s TriClip Reduces Severity Of Tricuspid Regurgitation Two-Year Results Confirm (MedTech Insight)
  • Exact Sciences Launches Cologuard Plus (MedTech Insight)
Government, Regulatory & Legal
  • HHS will not enforce gender and sexual orientation requirements for medical records (STAT)
  • Cassidy gave himself a difficult task. RFK Jr. isn’t making it any easier on him (STAT)
  • FDA tobacco official is removed from post in latest blow to health agency’s leadership (Reuters)
  • Ambitious NIH drive to solve brain mysteries faces uncertain future (STAT)
  • Vence Bonham, acting chief of National Human Genome Research Institute, ‘unexpectedly’ put on leave (STAT)
  • Nearly 2,000 top researchers call on Trump administration to halt ‘assault’ on science (STAT)
  • DC court sides with HHS in Vertex's fertility program fight (Endpoints)
  • FTC concerned about privacy protections in 23andMe bankruptcy (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.