Recon: FDA names Vinay Prasad as CBER director; Vertex halts trial of mRNA treatment for cystic fibrosis
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- RFK Jr. picks controversial doctor as top vaccine regulator (Axios) (STAT) (Reuters) (Endpoints) (Makary on X)
- Kennedy aide and vaccine critic questions recent expert recommendations (Reuters)
- US cancels FDA bargaining session over layoffs, union says (Reuters)
- Trump to continue Biden's court defense of abortion drug mifepristone (Reuters)
- FDA's top inspector abruptly retires (CBS News)
- New opioid data may not be generalizable, FDA adcomm says (Endpoints)
- Pharma Predicts Modest Tariff Impact, Depending On What Comes Next (Pink Sheet)
- Trump-Era Cuts, Harvard Fight Threaten Biotech’s Riskiest Bets (Bloomberg)
- Charles Lieber, ex-Harvard chemist convicted of lying about ties to China, joins faculty of Chinese university (STAT)
- How to stop the shift of drug discovery from the U.S. to China (STAT)
- Europe unveils $565 million package to retain scientists, and attract new ones (STAT)
- How to stop the shift of drug discovery from the U.S. to China (STAT)
- Trump signs order in bid to boost pharma manufacturing in the U.S. (STAT)
- Vertex reports an earnings miss and pause on cystic fibrosis trial (STAT)
- Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy (STAT)
- Dialysis firm FMC tops market expectations in 1st quarter (Reuters)
- Brian Armstrong’s NewLimit raises a $130M Series B, laying out road map for anti-aging drugs (Endpoints)
- Exclusive: Degradation startup raises $39M for pivot to PROTACs and clinical entry (Endpoints)
- Aldeyra plots third FDA filing for dry eye disease drug after latest Phase 3 data (Endpoints)
- PTC's Huntington’s study succeeds, but accelerated approval uncertain (Endpoints)
- Bristol Myers to lay off over 500 workers in New Jersey (Endpoints)
- Gene-Editor Synthego Files Bankruptcy With Plans to Sell Itself to Lenders (Bloomberg)
- Coloplast Seeks to Restore Investor Trust With Firing of CEO (Bloomberg)
- Danish Obesity Startup Ousia Gets Funds From US Investor Omega (Bloomberg)
- US semiconductor import probe looms over medtech industry (MedTech Dive)
- Philips cuts earnings forecast after calculating $340M tariff hit (MedTech Dive)
- Zimmer Biomet expects $60M to $80M tariff impact this year (MedTech Dive)
- Dexcom Puts Stelo On Amazon, Setting Up Consumer Showdown With Abbott (MedTech Insight)
- Tariff Pressures Creep Into Dexcom’s Margin Outlook Despite Domestic Manufacturing Shield (MedTech Insight)
- Harbinger Health Targets High-Mortality Cancers First With AI-Driven MCED Platform (MedTech Insight)
- The Obamacare Loophole Health Telemarketers Love (Bloomberg)
- Hartalega Expects Malaysian Glove Makers To Gain US Market Share (Bloomberg)
- Tyson Foods reformulates food products to eliminate synthetic dyes, CEO says (Reuters)
- A Cultural Shift: The Key to Consistent Listeria Management (Food Safety)
- FDA Job Cuts Spark Food Safety Debate (Forbes)
- 20 attorneys general ask federal judge to reverse deep cuts to HHS (STAT)
- Trump policies disrupt trials at NIH Clinical Center, researchers say (STAT)
- The entire U.S. health care system must be torn down and rebuilt (STAT)
- Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases (Pink Sheet)
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