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June 17, 2025
by Jason Scott

Recon: Lilly to acquire Verve in potential $1.3B deal; RFK Jr. eyes crackdown on drug ads

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

In Focus: US
  • Eli Lilly to buy gene-editing biotech Verve for up to $1.3 billion (STAT)
  • Purdue opioid settlement gets backing from 55 attorneys general (Endpoints)
  • What's coming in five years? FDA chief points to universal flu vaccine, new approval pathway (Endpoints)
  • US CDC official in charge of COVID, RSV data resigns ahead of vaccine meeting (Reuters)
  • FDA Announces New Vouchers to Cut Drug Reviews to Two Months (Bloomberg)
  • Orphan Cures Act dropped from Senate reconciliation bill (Fierce Pharma)
  • RFK Jr. Plans Crackdown on Pharma Ads in Threat to $10 Billion Market (Bloomberg)
In Focus: International                                                                                                       
  • China, where obesity levels are low, becomes hotbed for weight loss drug trials (STAT)
  • MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation (MedTech Insight)
  • EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others (Pink Sheet)
  • Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection (Pink Sheet)
  • Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars (Pink Sheet)
  • Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings (Pink Sheet)
Pharma & Biotech
  • Isomorphic Labs sets up U.S. presence, with an eye on clinical trials (STAT)
  • Obesity drugs don’t just offer weight loss. They give patients agency (STAT)
  • Mineralys gets a mid-stage win in hypertension patients with poor renal function (Endpoints)
  • Dyne pivots on primary endpoint, delays filing for DM1 drug (Endpoints)
  • Immuneering says MEK pill beats standard of care in first-line pancreatic cancer (Endpoints)
  • Blistering Rally in Herbal Medicine Stock Mints $26 Billion Fortune (Bloomberg)
Medtech
  • Could the FDA take an indirect approach to regulate LDTs? (MedTech Dive)
  • SS Innovations’ robot used in its 1st cardiac surgery in Americas (MedTech Dive)
  • Zyno recalls infusion pumps over unvalidated software (MedTech Dive)
  • Philips Deals Itself A Strong Hand In POCUS Stakes (MedTech Insight)
  • Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform (MedTech Insight)
  • Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy (MedTech Insight)
Food & Nutrition
  • Kraft Heinz to stop launching new products with artificial colors (Reuters)
  • White House health efforts need farm industry input, over 250 agriculture groups say (Reuters)
  • Turning Resistance into Opportunity: Motiving Change in the Food Industry (Food Safety)
Government, Regulatory & Legal
  • Doctors lose Medicare pay bump in Senate version of tax bill (STAT)
  • Senate GOP proposes steeper cuts to Medicaid funding in tax cut bill (STAT)
  • To boost Medicare Advantage profitability, Humana turns to old tactic: the annual wellness visit (STAT)
  • Private equity firm will finance Harvard research lab, in possible template for future (STAT)
  • Fresenius Medical Care's 2030 targets underwhelm market (Reuters)
  • Surgery Partners rejects Bain Capital's take-private offer (Reuters)
  • Ascension Health Expands Reach With $3.9 Billion AmSurg Deal (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.
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