Recon: FDA narrows search for new CBER director; Novo enters drug discovery pact with OpenAI

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

In Focus: US

• White House policies are ‘incredibly worrisome’ for small biotechs, Rhythm CEO says (Endpoints)
• FDA narrows in on search for new biologics and vaccines leader (Endpoints) (NBC)
• Wegovy-maker Novo Nordisk partners with OpenAI to speed drug development (Reuters)
• DOJ Says Biden Administration Protected Abortion Groups (Bloomberg)
• Another QMSR Town Hall – What Changes and What Stays the Same in FDA’s Inspection Process (FDA Law Blog)

In Focus: International

• A top WHO official confronts Iran war fallout, and weighs bid for an even bigger role (STAT)
• Tylenol in pregnancy not linked with autism, Danish study finds (Reuters)
• Global Fund expands commitment to improve access to HIV drug (Reuters)

Pharma & Biotech

• FDA seeks added safety data from Lilly on newly approved weight-loss pill (Reuters)
• My brother can’t access a just-approved breakthrough drug for his rare disease (STAT)
• Shedding caution, J&J makes bold claims for sales growth. Will it happen? (Endpoints)
• Biotech enthusiasm still high as Revolution Medicines leads $1.5B stock offering wave (Endpoints)
• Eli Lilly to acquire tiny Houston startup CrossBridge Bio for up to $300M (Endpoints)
• Parker Institute doubles down on cancer vaccines as part of ongoing reboot (Endpoints)
• FDA approves Travere's Filspari as the first drug for a rare kidney disorder (Endpoints)
• Exclusive: Click Therapeutics cuts 27% of workforce after $50M raise (Endpoints)
• PolyPeptide Studies Strategic Options as Private Equity Circles (Bloomberg)

Medtech

• Medline recalls angiographic syringes, receives FDA warning letter (MedTech Dive)
• Stryker to buy Amplitude Vascular Systems (MedTech Dive)
• GE HealthCare integrates ultrasound into Medtronic’s Stealth AXiS surgical system (MedTech Dive)
• Click Therapeutics Cuts Over 25% Of Staff After $50M Raise, CT-155 Commercial Shift (MedTech Insight)

Food & Nutrition

• Herbalife Revives Junk-Debt Sale After Shelving Deal Last Month (Bloomberg)
• Unilever Bets Big on Gummies as Next Frontier in Wellness (Bloomberg)

Government, Regulatory & Legal

• Maryland state affordability board sets its first price cap for a medicine (STAT)
• For Ben Sasse, Revolution Medicines’ pancreatic cancer trial felt like his best, only option (STAT)
• Dana-Farber CEO talks untangling from Mass General Brigham and building new cancer hospital (STAT)
• Access granted: CMS greenlights more than 150 participants for chronic care experiment (STAT)
• Zantac Lawsuits Tossed by Delaware Judge Over Flawed Cancer Link (Bloomberg)
• Millions of Floridians Will Bear the Brunt of Trump’s Health Cuts (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.