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February 25, 2025
by Jason Scott, Michael Mezher

Recon: Lilly to lower price of Zepbound vials; J&J alleges Samsung breached Stelara biosimilar contract

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

In Focus: US
  • Under siege after a tragedy, UnitedHealth grapples with fresh security threats and a customer backlash (STAT)
  • Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list (Reuters)
  • J&J sues Samsung over a contract breach for a Stelara biosimilar (STAT)
  • Pfizer CEO Albert Bourla inflicts injury on his company — and all of pharma (STAT)
  • Eli Lilly to lower price of Zepbound vials, offer more doses (STAT)
  • US FDA, CDC investigating multi-state listeria outbreak (Reuters)
  • FDA lifts hold on Entrada's Duchenne drug after two years (Endpoints)
  • DOGE-ing US FDA: Three Scenarios For What Comes Next (Pink Sheet)
  • Lawyer Kyle Diamantas Will Become Top Food Regulator at FDA (Bloomberg)
In Focus: International                                                                                                       
  • U.S. joins WHO-led flu vaccine meeting, despite planned withdrawal from agency (STAT)
  • Have Your Say: Should The EU Have eIFU For All Professional Use Devices? (MedTech Insight)
  • NSAI Hopes To Reverse IVDR Suspension By Irish National Authority In March (MedTech Insight)
  • Cross-Atlantic Alliance Sets Sights On First HTA Methods Recommendations (Pink Sheet)
  • EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others (Pink Sheet)
Pharma & Biotech
  • Why biotech’s future is threatened by zombies (STAT)
  • Hims & Hers shares plunge as looming curbs on drug compounding cloud forecast (Reuters)
  • Where the money is: The top 100 venture investors in biotech (Endpoints)
  • Alnylam eyes bigger diseases in more tissue types at ‘inflection point’ for siRNA (Endpoints)
  • 23andMe's CEO submits bid to take company private for $74.7M (Endpoints)
  • Harmony Gets Dissonant US FDA Response For Wakix In Idiopathic Hypersomnia (Pink Sheet)
Medtech
  • Smokescreen: some vape firms pivot after FDA crackdown (Reuters)
  • Thermo Fisher buys Solventum's purification and filtration business for $4.1 billion (Reuters)
  • Medtronic explores options to optimize manufacturing operations amid Trump's tariff threats (Reuters)
  • Guardant accuses Natera of poaching employees, stealing trade secrets (MedTech Dive)
  • New AI Tool Spots ‘Invisible’ Epilepsy Brain Lesions Missed By Radiologists (MedTech Insight)
  • ‘Most, If Not All,’ CDRH Staffers Back On The Job (MedTech Insight)
Government, Regulatory & Legal
  • Wins for bulk milk testing and deafness research (STAT)
  • What academic research could learn from college athletics (STAT)
  • Some NIH study sections will resume grant reviews, but final funding decisions are still in limbo (STAT)
  • ‘Ultra-processed food’ is too broad a term to be useful (STAT)
  • Alcon tried to sink Aurion's IPO in 'Valentine's Day massacre,' new lawsuits say (Endpoints)
  • Smartwatches Measuring Mortality Risks Are New Tool for Insurers (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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