Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug

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

In Focus: US

• Lilly enters psychedelic drug race with up to $3.8 billion AtaiBeckley deal (Reuters) (STAT)
• At key hearing, Kennedy’s ouster of former CDC director looms over nominee to replace her (STAT)
• FDA Approves First-of-Its-Kind Cholesterol Pill, Ushering In New Wave of Treatment (The Wall Street Journal)
• US drug shortages rise for third straight quarter, hurt by lone suppliers (Endpoints)

In Focus: International

• 'We're paranoid.' As China biotech competition heats up, American drugmakers get more secretive (Endpoints)
• Dassault Systemes in talks to buy drug trial software compaby for about $2bn (FT) (Reuters)
• UK experts recommend MenB vaccine for 15-year olds following big outbreak (Reuters)
• Italy's Angelini Pharma completes $4.1 billion state-backed takeover of Catalyst (Reuters)
• J&J Blames UK Impella Trial For Abiomed Decline As Q2 Cardiovascular Slips (MedTech Insight)
• India-UK Trade Deal: Lower Duties, Big Ambitions But Circumvention Still Unresolved (MedTech Insight)
• Pfizer suspends sales of Premarin vaginal cream in India, citing supply challenges (Reuters)
• UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success (MedTech Insight)
• No Early Fix For EU Joint Clinical Assessments Of Orphan Drugs (Pink Sheet)
• EMA’s €4,200 Penalty Fails To Stop Companies Delaying Drug Filings (Pink Sheet)

Pharma & Biotech

• Kalshi comes for biopharma, with prediction markets for clinical trials and FDA approvals (STAT)
• New study untangles how Epstein-Barr viral infection triggers immune response in multiple sclerosis (STAT)
• Amylyx nears pivotal endocrine drug study readout (STAT)
• The growing fang-to-pharmacy pipeline (STAT)
• Q&A: Betty Tijms says it’s time to stop treating Alzheimer’s as a single disease (Endpoints)

Medtech

• Brain implant restores the sensation of touch in a person with quadriplegia (STAT)
• FDA Warning Letters to ZIIP and Nihon Kohden Cite Device Marketing and Software Compliance Issues (MedTech Insight)
• Abbott raises 2026 profit forecast on strength in diagnostics, medical devices (Reuters)
• Vicarious Surgical board proposes dissolving the company (MedTech Dive)
• Zimmer Biomet names new Asia Pacific president (MedTech Dive)
• SS Innovations names Sarah Romano as CFO (MedTech Dive)

Food & Nutrition

• Medicaid and SNAP cuts are exacerbating the intertwined problems of hunger and mental illness (STAT)
• Defining ultraprocessed foods proves ‘challenging,’ FDA food head says (Food Dive)

Government, Regulatory & Legal

• CMS signals intent to revamp how it pays for clinical software and AI (STAT)
• UnitedHealth regains earnings momentum, shares surge (Reuters)
• After Decades Of Regulatory Stasis, CMS And CDC Signal CLIA Update May Be Coming (MedTech Insight)
• CVS Settlement With FTC Narrows Rebate-Based Pharmacy Benefit Options For Payers (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.