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May 12, 2025
by Jason Scott

Recon: Trump signs order to lower US drug prices; Lilly’s Zepbound beats Wegovy in weight loss study

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

In Focus: US
  • White House unveils sweeping plan to try to lower U.S. drug prices (STAT) (Reuters)
  • First at-home test kit for cervical cancer approved by the FDA, company says (STAT)
  • Beyond politics, even U.S. vaccine experts may envision fewer Covid shots in the future (STAT)
  • Eli Lilly's Zepbound outperforms Novo Nordisk's Wegovy for weight loss in trial (Reuters)
  • FDA, aiming to speed scientific reviews, names chief AI officer (MedTech Dive)
In Focus: International                                                                                                       
  • Pharma stocks recover from initial shock of Trump's drug pricing order (Reuters)
  • Bausch + Lomb receives CE mark for Luxlife intraocular lens (MedTech Dive)
  • Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector (MedTech Insight)
  • MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains (MedTech Insight)
  • UK Medtech Strategy Promises To Use Innovation Effectively And Build Resilience (MedTech Insight)
  • Will NICE’s New Medtech Evaluation Plans Hit the Target for Patients and Industry? (MedTech Insight)
  • Bill Gates to accelerate spending at his foundation — then wind it down (STAT)
Pharma & Biotech
  • Novartis to keep making malaria drugs if orders dry up amid aid cuts (Reuters)
  • Roche boosts US presence with new $700 million North Carolina facility (Reuters)
  • Exclusive: Patrick Hsu startup launches, looks beyond CRISPR for gene insertion technology (Endpoints)
  • Vir’s hep B disappointment, Ipsen's new Iqirvo data, plus more from #EASL25 (Endpoints)
  • FDA clears in vivo blood stem cell editing trial; Abeona's $155M PRV sale (Endpoints)
  • AstraZeneca Loses Spot as UK’s Most Valuable Company to HSBC (Bloomberg)
  • Pfizer partner touts HER2 ADC trial win in bladder cancer (Fierce Pharma)
Medtech
  • New Insulet CEO Ashley McEvoy sets priorities (MedTech Dive)
  • SEC ends probe of Illumina’s Grail acquisition (MedTech Dive)
  • ADA’s Osagie Ebekozien on diabetes tech for Type 2, new CGM standards (MedTech Dive)
  • The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist (MedTech Insight)
Food & Nutrition
  • FDA Approves Three Food Colors from Natural Sources (Food Safety) (FDA)
  • FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program (FDA)
Government, Regulatory & Legal
  • Science is under attack. So I’m taking RFK Jr. to court (STAT)
  • Pharmaceutical Manufacturer Assertio Therapeutics Inc. Agrees to Pay $3.6M to Resolve Allegations that It Violated the False Claims Act in Connection with Marketing its Fentanyl Product (DOJ)
  • House GOP unveils plans to reshape Medicaid (STAT)
  • Chinese and Chinese-American researchers in the U.S. confront a perilous moment (STAT)
  • Medicare Advantage challenges catch up to UnitedHealth (STAT)
  • From pandemic preparedness to precious frozen spit, NIH contract terminations cut deep (STAT)
  • Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA! (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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