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October 23, 2025
by Jason Scott

Recon: Moderna ends development of CMV vaccine; ICER finds launch prices for drugs ‘significantly’ higher than inflation

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

In Focus: US
  • Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You. (Pro Publica)
  • US could have saved $1.5 billion on costs with drug pricing linked to benchmark, says research firm (Reuters)
  • Launch prices for new drugs ‘significantly’ exceed inflation and offer insufficient value, analysis says (STAT) (ICER)
  • Drugmakers push to break ground after Trump's 100% tariff threat (Endpoints)
  • New IVF Policies Bring Hope — and Moral Questions (Bloomberg)
In Focus: International                                                                                                       
  • Merck KGaA to end API work at Irish plant after ‘strategic portfolio review’ (Endpoints)
  • Novo Nordisk Boardroom Clean-Out Is Rare Case of Director Accountability (Bloomberg)
  • Staar Surgical adjourns vote on acquisition by Alcon (Reuters)
  • Roche’s Quarterly Sales Drop as Major Drugs Miss Estimates (Bloomberg) (Reuters)
  • The NHS Tech Revolution Isn't All Hype (Bloomberg)
Pharma & Biotech
  • Tear down the wall between neurology and psychiatry (STAT)
  • Moderna says key study of its CMV vaccine, expected to be its next big win, failed (STAT) (Reuters)
  • Despite a tough year, Moderna forges ahead with cancer therapies (STAT)
  • Alkermes enters sleep medicine market with $2.1 billion Avadel deal (Reuters)
  • Anthropic’s biology head talks ‘Claude for Life Sciences’ (STAT)
  • West Pharma boosts annual profit forecast on strong demand for its drug components (Reuters)
  • How to tease out what’s causation and what’s just correlation (STAT)
  • Time is running out for Anavex and its treatment for Alzheimer’s disease (STAT)
  • Are recent strides in neurology R&D enough to make it a hot M&A target? (Endpoints)
  • Alector shares plunge after dementia drug fails to slow disease progression (Reuters)
  • Tango to advance pancreatic cancer drug into Phase 3, raises $225M (Endpoints)
  • Arcturus’ stock halved after mixed results of mRNA cystic fibrosis therapy, Covid-19 vaccine delay (Endpoints)
  • Lonza expects more CDMO contracts; Galderma's $650M US commitment (Endpoints)
  • Icon warns of macro environment headwinds as Medpace maintains revenue momentum (Endpoints)
  • Ventyx's stock soars on cardiovascular data for NLRP3 drug (Endpoints)
  • Micro-Doses of $200,000 Cancer Drugs Help Patients for Less (Bloomberg)
Medtech
  • Duke data scientist launches startup to help hospitals adopt AI (STAT)
  • European oncology experts roll out guidance for use of large language models in clinical care (STAT)
  • Hemorrhage can be a serious problem after pregnancy. Here’s how one medtech founder is tackling it (MedTech Dive)
  • Intuitive Surgical Leverages da Vinci 5 Upgrade Cycle To Expand Portfolio With Refurbished Xi (MedTech Insight)
Food & Nutrition
  • Your Protein Powder Isn’t Poisoning You (Bloomberg)
  • Food industry prepares to fight MAHA in states (Food Dive)
Government, Regulatory & Legal  
  •  YouTuber ‘Doctor Mike’ thinks medicine needs a better social media strategy (STAT)
  • Anti-science bills hit statehouses, stripping away public health protections built over a century (STAT)
  • The cost of health insurance for a family jumps to $27,000 (STAT)
  • UnitedHealth’s Optum Unit Gets Second New CFO in Six Months (Bloomberg)
  • Top RFK aide lashes out against healthcare industry for profiting off of illness (MedTech Dive)
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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