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May 6, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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
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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