Recon: FDA approves leucovorin for treating ultra-rare genetic disorder; BioNTech founders to launch new mRNA startup
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA widens use of leucovorin based on external controls, no new trial data (Endpoints)
- Novo Nordisk receives FDA warning regarding US inspection in 2025 (Reuters)
- Eli Lilly says some Medicare plans may exceed $50 cap for weight-loss drugs (Reuters)
- Seniors Paid Billions in Extra Premiums Due to Alleged Medicare Overpayments (The Wall Street Journal)
- Amazon launches healthcare AI assistant on its website, app (Reuters)
- China is going after the world's most expensive drugs: Endpoints Signal (Endpoints)
- EU-Swiss Agreement Good News For Innovative Drug Research, Says EUCOPE (Pink Sheet)
- Nordic Pilot On English-Only Drug Packs Grows, Backed By Positive Industry Response (Pink Sheet)
- Compliance Countdown Begins In EU For Revised Pharmacovigilance Guidance (Pink Sheet)
- How Clinigen Steered Prolacta’s Human Milk-Based Fortifier To Rx Medicine Approval In Japan (Pink Sheet)
- Removing race from kidney function algorithm helped more Black patients access transplants (STAT)
- Vertex says its drug successfully reduced marker of kidney disease in late-stage trial (STAT)
- STAT Plus:BioNTech founders to depart, form new mRNA-focused company (STAT)
- The Himsification of medicine (STAT)
- Breakout Ventures closes $114M fund, with plans for about 20 investments (Endpoints)
- Ipsen pulls cancer drug from market over safety risks (Endpoints)
- CSL firms up details on $1.5B US plasma-based medicines plant (Fierce Pharma)
- Filana leaves Cassava roots behind amid branch into epilepsy (Fierce Pharma)
- Emma Walmsley lands nearly 50% pay hike in final year as GSK CEO (Fierce Pharma)
- Lilly rewards CEO David Ricks with $36.7M pay package for 2025, fueled by GLP-1 success (Fierce Pharma)
- Sandoz Targets $650 Billion Opportunity With Biosimilars Unit (Bloomberg)
- Large drugmakers are developing fewer antibiotics, analysis finds (STAT)
- FDA drafts plan to cut down on biosimilar testing requirements (Fierce Pharma)
- Regulatory tracker: Daiichi, AZ's Enhertu wins FDA priority review in breast cancer subset (Fierce Pharma)
- SS Innovations raises $18.6M as surgical robot nears US market (MedTech Dive)
- Agilent to buy Biocare Medical for $950M (MedTech Dive)
- Vitestro Raises $70M In Series B To Expand Autonomous Blood-Draw Robot In Europe, Eyes US Approval (MedTech Insight)
- Medtronic Bolsters Neurovascular Portfolio With $550M Scientia Buy (MedTech Insight)
- Lindt says weight-loss drugs users are eating more chocolate, not less (Reuters)
- Gen Z and GLP-1 users drove record meat sales in 2025 (Food Dive)
- US Medicare Proposes Buy American Rx Incentives, But What Is A ‘Domestic’ Medicine? (Pink Sheet)
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