Recon: FDA adcomm votes against Capricor’s DMD drug; Cytokinetics gets UK approval, NICE backing for heart drug

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

In Focus: US

• Tracking the FDA expert review of Replimune’s melanoma treatment (STAT)
• FDA expert panel recommends against approval of Capricor’s Duchenne drug (STAT)
• FTC sues Hims & Hers over alleged privacy violations, deceptive billing practices (MedTech Dive)
• Lilly, Resilience to invest $750 million in US drug manufacturing expansion (Reuters)
• US Senate panel advances Trump CDC pick Schwartz (Reuters)
• The FDA was all in on AI. Will that change? (MedTech Dive)

In Focus: International

• Merck, Wellcome partner with global health group to make Ebola vaccine for clinical trials (Reuters)
• Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases (STAT)
• U.S. dependence on China is a national security risk (STAT)
• India takes action against 90% of inspected high-risk pharmaceutical facilities, regulator says (Reuters)
• Cytokinetics wins UK approval, NICE backing for heart disease drug (Reuters)

Pharma & Biotech

• Latigo reports mid-stage success for would-be rival to Vertex’s pain drug Journavx (STAT)
• Rising oil prices can boost the cost of some medicines. One expert says it’s time to lower reliance on fossil fuels (STAT)
• Braveheart Bio targets $1.2 billion valuation in US IPO (Reuters)
• Sanofi drug pipeline worries, Dupixent dependence shake shares (Reuters)
• Pfizer takes Litfulo to regulators in vitiligo challenge to Incyte, AbbVie (Fierce Pharma)
• Alnylam shares tank 29% as Amvuttra disappoints with ATTR outlook cut for 2026 (Fierce Pharma)
• New CEO Garijo sketches out vision to reverse Sanofi's fortunes as Q2 delivers impressive sales beat (Fierce Pharma)

Medtech

• Boston Scientific to restructure, taking up to $800M in charges (MedTech Dive)
• Clinical-Evidence Debate And Electrophysiology Rivals Cool Boston Scientific’s Hottest Franchises (MedTech Insight)
• What J&J’s Ottava robot brings to the surgical table (MedTech Dive)
• Boston Scientific again cuts 2026 guidance (MedTech Dive)
• Abbott starts TriClip study amid rising competition for heart valve repair (MedTech Dive)
• GE HealthCare Posts Best Orders Quarter Since 2023 Spinoff, But Payoff Is Deferred To 2027 (MedTech Insight)

Food & Nutrition

• Is it safe to drink Red Bull and alcohol? Questionable research tied to energy drink giant has shaped policy (Food Dive)
• Cyclosporiasis cases in Michigan rise to 10,386 in ongoing outbreak (Reuters)
• UK reports rise in cyclospora infections linked to Mexico travel (Reuters)

Government, Regulatory & Legal

• Chronically ill people face confusion over new Medicaid work rules and ‘medically frail’ exemption (STAT)
• NSF testing new Ph.D. model giving trainees academic and industry experience (STAT)
• Cigna raises annual profit forecast on strength in specialty drug unit (Reuters)

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.