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)
- 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)
- 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)
- 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)
- 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)
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