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August 14, 2025
by Jason Scott

Recon: Pharma industry nears clarity on GDPR application for PV, trials; Investors warier than ever of funding mRNA vax

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Trump administration leaves biotech investors more wary than ever of funding mRNA vaccines (STAT)
  • U.S. warning on use of ‘march-in’ rights against Harvard seems like distant threat for pharma (STAT)
  • Kennedy’s case against mRNA vaccines collapses under his own evidence (STAT)
  • ‘Makes No Sense': Experts Push Back On RFK Jr.’s Doubts About Hepatitis B Vaccine (MedPage Today)
  • Drugmakers form new group to lobby on impact of Medicare drug price negotiations (STAT)
  • Lilly gets another obesity partner in deal with Superluminal worth up to $1.3B (Endpoints)
  • Trump executive order focuses on stockpiling raw materials for 'critical' drugs (Endpoints)
 
In Focus: International                                                                                                                                         
  • Lilly to hike UK price of Mounjaro weight-loss drug by 170% (Reuters)
  • Swiss Ministers Meet With Roche, Novartis Amid Tariff Crisis (Bloomberg)
  • GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey (Pink Sheet)
  • UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials (Pink Sheet)
  • Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules (Pink Sheet)
  • Brazil’s Medtechs Look to Solutions After 50% US Tariff Hit Amid ‘Scenario of Uncertainty’ (Medtech Insight)
 
Pharma & Biotech
  • ADHD Medicines Reduce Suicide, Crime Risks in Sweeping Study (Bloomberg)
  • Duke scientists seemed to have developed a ‘Holy Grail’ of cancer treatment. Then the truth came out (STAT)
  • No Chemo Benefit in Older Women With High-Risk HR-Positive Breast Cancer (MedPage Today)
  • Popular Diabetes Drugs Linked to Small Risk of Retinal, Optic Nerve Disorders (MedPage Today)
  • GLP-1 Drugs May Hold Benefit in Painful Skin Disease (MedPage Today)
  • Early Treatment Shows Benefit in Infants With Presymptomatic Genetic Disease (MedPage Today)
  • Schrödinger ends work on blood cancer drug after two patient deaths (Endpoints)
  • Fertility startup Gameto raises $44M to fund Phase 3 study of stem cell IVF therapy (Endpoints)
  • In the scramble for capital, biotechs turn to royalty deals (Endpoints)
  • Sarepta sells Arrowhead stake for cash and to help fulfill milestone payment (Endpoints)
  • Vedanta's microbiome therapy fails Phase 2, company lays off 20% (Endpoints)
 
Medtech
  • OpenAI can’t have it both ways on GPT-5 and health (STAT)
  • Japan’s green light for making human embryos from stem cells takes us into uncharted territory (STAT)
  • Apple Watch Blood Oxygen Tracker Back in US With Workaround (Bloomberg)
  • Whoop Refuses to Pull Blood Pressure Tool After FDA Warning (Bloomberg)
  • Shan Jegatheeswaran shares J&J’s vision for AI in the OR (MedTech Dive)
 
Food & Nutrition
  • Brain Autopsies Suggest MIND Diet Reduces Pathology (MedPage Today)
  • Daring Foods acquired by one of Australia’s biggest plant-based meat producers (Food Dive)
 
Government, Regulatory & Legal  
  • Trump Order Gives Political Appointees Review of Scientific Grants (MedPage Today)
  • Aluminum in Vaccines Study Won't Be Retracted, Journal Says (MedPage Today)
  • Costco Won’t Sell Abortion Pill as Religious Investors Declare Win (Bloomberg)
  • CDER White Paper Promotes FDA’s View of the Benefits of Investing in Pharmaceutical Quality (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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