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June 30, 2025
by Jason Scott

Recon: Republicans revise healthcare measures in tax bill; EU countries rally behind pathway for IVD/drug trials

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Orphan Cures Act re-added to Trump tax bill as Senate prepares to begin vote-a-rama (Fierce Pharma)
  • AbbVie snaps up CAR-T company in a deal worth $2.1 billion (STAT)
  • Senate GOP tweaks health care measures in tax bill to win holdouts, please parliamentarian (STAT)
  • Moderna’s Flu Vaccine Hits Goal, Paving Way for Combo Shot (Bloomberg)
  • Europe, US Make Encouraging Noises on Trade Deal (Bloomberg)
 
In Focus: International                                                                                                                                         
  • First China Weight Loss Drug Rival to Novo, Lilly Emerges (Bloomberg)
  • UK Center To Develop Brain Stimulation Devices Opens (MedTech Insight)
  • Apple Tree Partners' biotechs 'face imminent collapse' as firm battles Russian investor in court (Endpoints)
  • No ‘Doomsday’ For US Pharma Despite Political Uncertainties, EU Industry Chief Says (Pink Sheet)
  • EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials (Pink Sheet)
 
Pharma & Biotech
  • Mineralys’ Drug Significantly Cut Blood Pressure in Key Study (Bloomberg)
  • Torrent Pharma Said to Get $2.3 Billion Credit Line for JB Buy (Bloomberg)
  • Amgen’s stomach cancer drug boosts survival in Phase 3, but ocular side effects leave questions (Endpoints)
  • Hikma pledges $1B to expand US manufacturing presence (Endpoints)
  • Unicycive gets a CRL for chronic kidney disease pill as third-party production issues linger (Endpoints)
  • Sage lays off entire staff of 338 amid Supernus acquisition (Fierce Pharma)
  • The top 10 pharma drug ad spenders of 2024 (Fierce Pharma)
  • At Aspen Ideas, a life science VC sees cause for long-term optimism despite a rocky market (STAT)
 
Medtech
  • New blood test could predict preeclampsia in the first trimester (STAT)
  • OpenAI-backed startup releases new AI models, claiming top performance in making antibodies (Endpoints)
  • No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market (MedTech Insight)
  • Danaher appoints Martin Stumpe as chief technology and AI officer (MedTech Dive)
  • Olympus pledges prompt response following FDA import block (MedTech Dive)
 
Food & Nutrition
  • JM Smucker latest food maker to commit to removing artificial dyes (Food Dive)
  • Imported Seafood Found to be a Source of Antimicrobial Resistance Genes (Food Safety)
  • Talc Isn't Just in Baby Powder. It's Also in Vitamins and Drugs (Bloomberg)
 
 
Government, Regulatory & Legal
  • RFK Jr. says medical journals are ‘corrupt.’ As former NEJM editors, we know he’s wrong (STAT)
  • The U.S. must invest in mRNA vaccines against pandemic influenza viruses now (STAT)
  • Fallout from Trump’s battle with Harvard extends far beyond Boston (STAT)
  • RFK Jr.’s Vaccine Panel Is Turning Misinformation Into Policy (Bloomberg)
  • The RFD Process: Time for Reform? (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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