Recon: FDA approves Merck's Welireg-Keytruda combo for kidney cancer; FDA staff signal support for Moderna’s flu shot in older adults
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Merck's Welireg-Keytruda pairing sticks the landing in adjuvant kidney cancer treatment with new FDA nod (Fierce Pharma)
- Moderna flu shot data may support use in older adults, US FDA staff says (Reuters)
- Sanofi’s Tzield Regulatory Rollercoaster Ride Ends Without NPV, But With New Claim (Pink Sheet)
- ‘Shout It From The Mountaintop:’ Making Clinical Trial Quality Everyone’s Business (Pink Sheet)
- CMS Targets Combo Drug Workaround Used To Dodge Medicare Drug Price Negotiation (Pink Sheet)
In Focus: International
- Novo Nordisk to seek approval soon to sell Wegovy pill in China (Reuters)
- Congo Ebola outbreak may be worst ever, Africa CDC says (Reuters)
- G7 leaders call for strong, coordinated response to Ebola outbreak (Reuters)
- India’s Pharma Billionaire Eyes Crown of World’s Top Insulin Supplier (Bloomberg)
- Madrigal Cooperating With NICE On MASH Drug After Provisional English Funding Rejection (Pink Sheet)
Pharma & Biotech
- Moderna hires Novartis vet to lead commercial, upsizes role for Hoge as potential launches loom (Fierce Pharma)
- Human Cell Atlas leader’s tie to 10x Genomics raises conflict-of-interest questions (STAT)
- Verge Labs’ new AI model solves patient stratification problems for neurology clinical trials (STAT)
- Ebola Bundibugyo vaccine candidates could enter Phase 1 trials as early as July (Reuters)
- EMA Finds Paternal Valproate Risk Uncertain, Maintains Precautions (Pink Sheet)
Medtech
- No Single Partner: How Leading Hospital Systems Are Building Multi-Vendor AI Ecosystems (MedTech Insight
- J&J Pledges $1bn To Expand Florida’s ACUVUE Contact Lens Operations (MedTech Insight)
- Stelo Pediatric 510(k) Clearance Marks First OTC CGM For Children, Backed By Real-World Data (MedTech Insight)
- Not Getting WISeR: Lawmakers Seek To Block Funding For AI Medicare Authorization Model (MedTech Insight)
- FDA Issues Warning to Maker of $1,700 Snoo Baby Bassinets (Bloomberg)
Food & Nutrition
- Cholesterol Guidelines Get a Welcome Overhaul (Bloomberg)
- RFK Wants You to Eat Real Food. MAGA Is Making It More Expensive (Bloomberg)
Government, Regulatory & Legal
- Congress must reauthorize the Pandemic and All-Hazards Preparedness Act (STAT)
- IQVIA taps AI to put overlooked prescribers on marketers’ maps (Fierce Pharma)
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.
