Recon: FDA approves Egetis’ Emcitate for rare genetic disease; Novo buys rights to Chinese weight-loss pill in $2.6B deal
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Egetis Therapeutics' Emcitate cleared by FDA for rare X-linked genetic disease (Endpoints) (FDA)
- Pharma's new top lobbyist is former Majority Leader Eric Cantor (Politico) (Reuters)
- FDA’s accelerating rare disease cures program proved its concept, can it drive review practice? (Pink Sheet)
- FDA’s plausible mechanism framework: Trials must be infeasible, not just challenging (Pink Sheet)
- Is restoring US biotech leadership FDA’s top priority? (Pink Sheet)
- Reorg cuts FDA chief counsel oversight position at HHS (Pink Sheet)
- VA institutes new consent requirements for some psychiatric drugs (New York Times)
- CDC confirms two measles-related deaths in 2026 (Reuters)
- AstraZeneca files for US FDA approval of HUTCHMED lung cancer drug combination (Reuters)
- Amazon, GoodRx target US prescription subscribers as health insurance coverage slips (Reuters)
In Focus: International
- Novo to pay up to $2.6 billion to China's Hengrui for rights to weight-loss pill (Bloomberg) (Financial Times)
- EU pharma reform package takes step forward with formal council adoption (Pink Sheet)
- EU aligns safety reporting for combined drug-IVD/device studies, but double reporting persists (Pink Sheet)
- ARCH and Population Health return to China for new startup, targeting sleep disorders (Endpoints)
- Australia's CSL taps Amazon's cloud unit to boost research pipeline (Reuters)
- India's Sun Pharma plans $1 billion local debt sale for loan takeout, sources say (Reuters)
Pharma & Biotech
- AstraZeneca buys a $2B stake in Summit, taking equity in bet on cancer drug (Endpoints) (BioPharma Dive)
- Adicet Bio shares promising look at CAR-T for lupus, but stock drops anyway (Endpoints) (BioPharma Dive)
- Kodiak's stock soars as it clinches crucial Phase 3 win for Eylea competitor (Endpoints) (BioPharma Dive)
- UniQure’s gene therapy continues to slow Huntington’s progression after four years (STAT) (Fierce Biotech)
- Merck discontinues a crucial antibiotic despite concerns over superbug resistance (STAT)
- Roche cans muscle-preserving obesity drug, hands it back to Chugai (Endpoints)
- Novo says Ozempic shows lower risk of cardiovascular events compared to Lilly's Mounjaro (Reuters)
- Lilly touts Foundayo advantage over Novo's Ozempic pill in diabetes analysis (Reuters)
- Genentech AI alumni launch health startup Ortet with $500M (Endpoints)
- Swedish biotech AnaCardio raises $70.9M for 'safer' heart drug (Endpoints)
Medtech
- California firm wins breakthrough designation for stimulant use disorder device (Medtech Insight)
- XVIVO files heart assist transport PMA, targets 2027 US launch (Medtech Insight)
- The last ‘breakthrough’ devices to get special treatment from Medicare (STAT)
- EASD: Abbott, Dexcom studies show CGMs reduce mortality; patient awareness still concern (Medtech Insight)
- Sofinnova partners closed $93.4M MD Start IV fund with plans to launch 6-8 start-ups (Medtech Insight)
- AI-powered CT moves from diagnostic tool to CAD care platform (Medtech Insight)
Food & Nutrition
- New California law creates non-ultra-processed food seal (Food Safety News)
- FDA increases enforcement against imported food adulterated for economic gain (Food Safety News)
Government & Legal
- White House takes stock of US-based manufacturing for 86 essential drugs (Endpoints)
- Trump administration asks Supreme Court to allow transgender medical care restrictions in prison (STAT)
- US House Democratic Women's Caucus press health secretary on estrogen patch shortages (Reuters)
- Why MAHA wants to make health data much more accessible (STAT)
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.
