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March 31, 2025
by Jason Scott

Recon: Drugmakers sink after Marks’ ouster; Lilly’s drug slashes genetic heart disease risk in late-stage trial

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

In Focus: US
  • It’s RFK Jr.’s FDA now (STAT)
  • Peter Marks, FDA’s top vaccine regulator, forced out (STAT)
  • New FDA commissioner agreed to oust top vaccine regulator after private swearing-in (Politico)
  • Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally (STAT)
  • Drugmakers sink after key FDA official ousted as Trump plans health overhaul (Reuters)
  • HHS emergency response unit given two days to figure out its fate (STAT)
  • Trump chooses Fox News contributor Sara Carter as next drug czar (STAT)
  • Drugmakers sink after key FDA official ousted as Trump plans health overhaul (Reuters)
  • Experimental Lilly drug cuts genetic heart disease risk factor by 94% in trial (Reuters)
In Focus: International                                                                                                       
  • Eli Lilly’s Alzheimer’s drug gets thumbs-down from European regulators (STAT)
  • European institutions target ‘scientific asylum-seekers’ from US (The Hill)
  • Chinese brain chip project speeds up human trials after first success (Reuters)
  • Lassa fever kills 118 in Nigeria over last three months (Reuters)
  • WHO proposing to cut jobs and slash budget by a fifth, memo shows (Reuters)
Pharma & Biotech
  • Emotional whiplash for PTC Therapeutics (STAT)
  • Novo Nordisk sets sights on new type of oral obesity drug (STAT)
  • Alphabet’s Isomorphic Labs raises $600M in biotech’s largest round of 2025 (Endpoints)
  • Inspirna, which was preparing for a Phase 3 cancer trial, has folded (Endpoints)
  • Lilly's heart disease drug could be dosed as little as once a year, study shows (Endpoints)
  • Corcept's ovarian cancer drug cuts disease progression in study, shares jump (Reuters)
  • Exclusive: Transcend notches Phase 2 win to treat PTSD, invigorating budding neuroplastogen class (Endpoints)
  • BiomX’s phage therapy succeeds in Phase 2 diabetic bone infection study (Endpoints)
  • Exclusive: SV Health debuts Parkinson's biotech with backing from AbbVie and others (Endpoints)
  • Vertex’s second-generation diabetes cell therapy fails early-stage study (Endpoints)
Medtech
  • FDA OKs first at-home test for 3 STIs (MedTech Dive)
  • Tandem eyes Medicare coverage expansion for Type 2 (MedTech Dive)
  • How Cutting Edge Technology Is Changing Risk Management In the EU (MedTech Insight)
  • LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy (MedTech Insight)
Food & Nutrition
  • Requirements for Mandatory Foodborne Pathogen WGS Analysis, Data Submission in EU (Food Safety)
  • Boar’s Head Appoints Natalie Dyenson as Chief Food Safety Officer (Food Safety)
Government, Regulatory & Legal
  • Utah bans fluoride in public drinking water, a first in the U.S. (STAT)
  • Amgen loses its battle against Colorado over a prescription drug affordability board (STAT)
  • Big Tobacco targets Trump in hope - and fear - of change (Reuters)
  • It’s a Bird, It’s a Plane, It’s Operation Stork Speed (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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