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29 May 2025
by Jason Scott

Recon: US cuts $700M in funding for Moderna bird flu vaccine; FDA approves Alcon’s dry eye drug

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

In Focus: US
  • As the FDA and NIH eschew animal testing, startup raises $40 million for lab-grown organs (STAT)
  • Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements (STAT)
  • Merck, Daiichi Sankyo scrap FDA application for HER3 ADC after survival miss (Endpoints)
  • Large pharma companies spell out reasons why tariffs will harm US investments (Endpoints)
  • US cancels more than $700 million funding for Moderna bird flu vaccine (Reuters)
  • US FDA approves Alcon's new dry-eye drug (Reuters)
  • RFK Jr. Slams Medical Journals, Floats In-House Publishing Plan (Bloomberg)
  • RFK Jr’s ‘Maha’ report found to contain citations to nonexistent studies (The Guardian)
In Focus: International                                                                                                       
  • Sanofi’s vaccine tech transfer in Vietnam; Almac’s £1B+ revenue milestone (Endpoints)
  • Brazil declared free of foot-and-mouth disease without vaccination (Reuters)
  • China investigating former head of food and drug watchdog (Reuters)
  • FDA finds Chinese lab copied or falsified data, endangering patients (MedTech Dive)
  • UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth (MedTech Insight)
Pharma & Biotech
  • PillPack founders’ new health care marketplace has deep roots with Amazon (STAT)
  • CHAI’s ‘assurance lab’ effort is dead. Long live the assurance lab. (STAT)
  • DNA giant Illumina spawned an ecosystem of competitors and customers (Endpoints)
  • FDA rejects Stealth's rare disease drug, but offers potential for accelerated approval (Endpoints)
  • Taysha’s pivotal trial plans; Keros to stop work on PAH drug, lay off 45% of staff (Endpoints)
  • Oric locks down cash for Phase 3 prostate cancer trial with early data in hand (Endpoints)
  • PepGen ditches Duchenne programs after mid-stage fail, switches to previously halted muscle wasting therapy (Endpoints)
  • Intellia reports case of liver toxicity in ATTR gene editing study (Endpoints)
  • Omada Health targets valuation of over $1 billion in US IPO (Reuters)
  • Cancer Drugs Cost More Than Ever. They Often Don't Extend Lives (Bloomberg)
Medtech
  • AI-based mammography is here, and it has a trust problem (STAT)
  • The medtech IPO window is finally open. Or is it? (MedTech Dive)
  • US court blocks Trump’s sweeping tariffs (MedTech Dive)
  • Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition (MedTech Dive)
Food & Nutrition
  • General Mills to cut jobs as part of multi-year restructuring plan (Food Dive)
  •  Töst aims to reach moderate drinkers with sophisticated mocktails (Food Dive)
  • FSAI Seeks Public Input on Food Hygiene Rating Scheme (Food Safety)
  • USDA Secretary Rollins Increases Funding to Reimburse States for Food Safety Inspections (Food Safety)
Government, Regulatory & Legal
  • Amid measles outbreak, Texas is poised to make vaccine exemptions for kids easier (STAT)
  • How we beat anti-vaccination bills in North Dakota (STAT)
  • With aura readings and a Lauryn Hill concert, Philip Morris rolls out a new tobacco product in the U.S. (STAT)
  • With Covid vaccine decisions, RFK Jr. unleashes an unfettered assault on public health (STAT)
  • Another Lever That Can Be Used to Slow Inflation: Healthcare (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.