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August 25, 2025
by Joanne S. Eglovitch

Recon: AbbVie to purchase Gilgamesh’s psychedelic therapy for potential $1.2B; FDA pauses Valneva's chikungunya vaccine license

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

In Focus: US
  • As MAHA turns 1, a fired-up movement is still figuring out how to fulfill its promises (STAT)
  • AbbVie to buy Gilgamesh’s psychedelic drug for up to $1.2 billion (STAT)
  • FDA says it will publish reports of adverse events tied to drugs on daily basis (STAT)
  • US CDC taps vaccine skeptic to lead COVID vaccine committee (Reuters)
  • FDA suspends license for Valneva's chikungunya vaccine amid safety concerns (Endpoints)
In Focus: International                                                                                                                                
  • China screened 600 million for disease, keeping up COVID-era controls (Reuters)
  • Botswana Declares Health Crisis as Low Diamond Demand Hits State Medical Funds (Bloomberg)
  • MedTech Europe sounds alarm over impact of US-EU tariffs on patients (MedTech Dive)
  • German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov (MedTech Insight)
Pharma & Biotech
  • Gene-edited pig lung transplanted into a brain-dead patient for first time (STAT)
  • Testosterone made me feel 30 again — until it nearly broke my heart (STAT)
  • The future of medicine lies in multifunctional therapies (STAT)
  • Merck looks to modest HIV business as a $5B underdog (Endpoints)
  • Akeso reports positive Phase 3 readouts from two inflammation-tackling antibodies (Endpoints)
  • BeOne to get $885M upfront in royalty deal over Amgen’s Imdelltra (Endpoints)
  • MannKind to buy scPharmaceuticals for up to $360M; Arnatar launches with $52M (Endpoints)
  • LB Pharmaceuticals seeks IPO as cash runs dry for looming Phase 3 schizophrenia trial (Endpoints)
  • Biotechs Turn to Digital Coins, Crypto to Boost Stock Prices (Bloomberg)
  • Mitsubishi Is Said to Near Investment in Fullerton Health (Bloomberg)
  • With late-stage trial win, Argenx preps FDA filing to push Vyvgart into broader myasthenia gravis population (Fierce Pharma)
Medtech
  • He was 21 when he programmed MyChart. Now he’s the president of Epic (STAT)
  • Terumo Buying Organ Tech Provider OrganOx for $1.5 Billion (Bloomberg)
  • Ransomware attack on DaVita exposes data from 2.7M (MedTech Dive)
  • The robotic surgery market battle is heating up (MedTech Dive)
Food & Nutrition
  • Grocers’ meat departments show resilience amid economic woes: report (Food Dive)
  • Foodservice sector navigates headwinds (Food Business News)
Government, Regulatory & Legal  
  • Amid cries for retraction, a medical journal reviews a discredited, 24-year-old paper on an antidepressant (STAT)
  • Royalty Pharma to pay up to $950 million for royalties from Amgen's lung cancer drug (Reuters)
  • Ozempic teeth: Dentists warn of new GLP-1 side effect (The Hill)
  • HHS derecognizing unions representing staffers at CDC, FDA, NIH and more (The Hill)
 
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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