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October 7, 2025
by Jason Scott

Recon: Peter Marks joins Eli Lilly to head infectious disease unit; AstraZeneca blood pressure drug hit main goal in Phase 3 trial

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

In Focus: US
  • Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly (STAT)
  • Parents are flocking to natural and ‘clean medicine’ brands. Medical experts are worried (STAT)
  • Acting CDC director calls for MMR vaccine to be broken up into three shots (STAT)
  • J&J ordered to pay $966 million in talc cancer case after jury finds company liable (Reuters)
  • Novo Nordisk cuts hit production line jobs at key US plant (Reuters)
  • Inside Warning Letters: A Statistical Update (FDA Law Blog)
  • Trump Opens Door to Talks GOP Has Resisted as Shutdown Extends (Bloomberg)
  • White House memo says furloughed federal workers aren't entitled to back pay (Axios)
In Focus: International                                                                                                       
  • With much to win (or lose), drugmakers and European officials bear down on major policy overhaul (STAT)
  • Case Study: Pushing The EU’s IVD Regulation To Its Limits With Next Generation Sequencing (MedTech Insight)
  • Eli Lilly earmarks $1B to boost India manufacturing footprint (Endpoints)
  • AstraZeneca drug baxdrostat cuts blood pressure in key late-stage trial (Reuters)
  • Defining Unmet Medical Need: EU Debate Sparks Concern Over Innovation And Access (Pink Sheet)
  • ‘Urgent Need’ To Scale Up Advice Slots Under EU HTA Regulation – EUCOPE (Pink Sheet)
  • Novo Ex-CEO Jorgensen Gets New Job at Danish Health-Care Lobby (Bloomberg)
  • Prosthetics maker Ottobock plans to raise $941 million in German IPO (Reuters)
Pharma & Biotech
  • Drug developer MapLight eyes $704.3 million valuation in US IPO (Reuters)
  • Soufflé Therapeutics, co-founded by Bob Langer, launches with $200M (Endpoints)
  • Mark Alles’ biotech gets $96M for ADCs from UCLA lab (Endpoints)
  • Lexeo eyes faster path to approval for Friedreich's ataxia gene therapy (Endpoints)
  • Adicet reveals Phase 1 data for lupus therapy; Arcus’ ‘best-in-class’ kidney cancer drug (Endpoints)
  • Biopharma makes little progress on gender diversity, as women make up 11% of CEO ranks (Endpoints)
  • Biomea shares early Phase 2 diabetes data from repurposed cancer candidate (Endpoints)
  • AeroRx closes $21M Series A in bid to capitalize on COPD momentum (Endpoints)
  • Engineered Protein That Responds to Light Could Help Restore Sight (Bloomberg)
Medtech
  • How the FDA’s crackdown on cybersecurity affects medtech firms (MedTech Dive)
  • How 4 medtech CEOs are using AI (MedTech Dive)
  • AdvaMed Warns Of Challenges With Remote Devices While Noting Their Potential (MedTech Insight)
  • Convatec plans $1B investment in R&D in the US and UK (MedTech Dive)
Food & Nutrition
  • AI is set to transform the way consumers shop for food (Food Dive)
  • Tyson agrees to record $85M settlement in pork price-fixing lawsuit (Food Dive)
Government, Regulatory & Legal  
  • They advised federal health agencies on the ethics and impact of scientific research. They’re no longer wanted (STAT)
  • What RFK Jr. gets wrong about medical school and nutrition education (STAT)
  • US health official calls for separating measles combination shots, pulls broad COVID vaccine support (Reuters)
  • Gilead inks Biktarvy settlements with 3 generic drug makers (Fierce Pharma)
  • TV drug ad spending picked up in September despite federal crackdown (Fierce Pharma)
  • Massachusetts Effort to Offset Trump’s Research Cuts Stalls (Bloomberg)
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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