Recon: Makary to resign as FDA commissioner; EU reaches draft deal on Critical Medicines Act

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

In Focus: US

• Makary’s time atop FDA over, Diamantas named acting commissioner (Politico)
• Supreme Court temporarily extends women’s access to a widely used abortion pill (STAT)
• Hims & Hers plunges after weight-loss pivot hits quarterly results (Reuters)
• RFK Jr.: ‘We’re not worried’ about hantavirus spreading after cruise ship outbreak (The Hill)
• US says 18 passengers flown back after hantavirus outbreak on ship (Reuters)

In Focus: International

• Pharma and biotech leaders are destroying their own industry (STAT)
• Bristol Myers Squibb partners with China’s Hengrui Pharma on a dozen drugs (STAT)
• Colombia wins a key court ruling over a compulsory license issued for an HIV medicine (STAT)
• EU agrees draft deal to tackle essential medicine shortages (Reuters)
• Africa CDC and Aspen Pharmacare aim to boost vaccine output in Africa (Reuters)
• India's Dr Reddy's plans generic Ozempic launch in Canada this month, eyes India semaglutide tablet roll-out (Reuters)
• Exclusive: Lilly halts India obesity awareness campaign after regulatory scrutiny, seeks rules clarity (Reuters)

Pharma & Biotech

• In the battle of sepsis algorithms, performance alone doesn’t predict victory (STAT)
• Small study shows one-time cell therapy can control HIV infection (Reuters)
• Flagship startup says it has solved non-viral gene therapy in monkeys, but details remain murky (Endpoints)
• Rezdiffra is exceeding Wall Street's expectations as the MASH market takes shape (Endpoints)
• Optum Rx unveils pharmacy model with clear fees, building on transparency push (Endpoints)
• Daiichi eyes almost $15B in oncology sales by 2030 in ADC franchise push (Endpoints)
• BridgeBio stands up to Pfizer in ATTR-CM as late-stage data hint at better survival (BioSpace)
• More Evidence that GLP-1s May Reduce Risk of Vision-Robbing Eye Diseases (MedPage Today)

Medtech

• Roche’s Alzheimer’s Blood Test Achieves CE Marking, One Day After Fujirebio (MedTech Insight)
• Mobia Medical Goes Public, Banking On Sole FDA-Approved Stroke Implant (MedTech Insight)
• Workouts, TV and Hantavirus Tests: Inside the US Quarantine Unit (Bloomberg)

Food & Nutrition

• Despite its toll, alcohol is still an awkward subject in the doctor’s office (STAT)
• Bayer Q1 operating profit jumps 9% on boost from soy business (Reuters)
• Food-as-Medicine Intervention Signals BP Benefit in High-Risk Adults (MedPage Today)

Government, Regulatory & Legal

• Patients jockey for exemptions from Medicaid’s new work requirements (STAT)
• White House proposal encourages companies to offer fertility treatment benefits (The Hill)

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.