Recon: FDA approves Insmed’s chronic lung disease drug; Sanofi halts supply of cholesterol drug to China due to supply constraints
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA approves Insmed's drug as first treatment for a chronic lung disease (Reuters)
- NIH director: mRNA vaccine contracts were canceled because public lacks trust in technology (STAT)
- RIF packets from FDA included sensitive data for other workers, sources say (Fedscoop)
- Eli Lilly, Pfizer Seek Spot in China Private Insurance Catalog (Bloomberg)
- FDA Weighs Pulling Pfizer’s Covid Vaccine for Kids Under Age 5 (Bloomberg)
- How FDA Drama Is Roiling Biotech Stocks (Bloomberg)
- Community pharmacies are in crisis. Three things need to change (STAT)
- Editorial: Dear Vinay: Please embrace dissent and fade into the background (STAT)
- Cardinal Health to buy Solaris Health for $1.9 billion, posts weak results (Reuters)
- Sanofi stops supply of high cholesterol drug to China due to limited availability (Reuters)
- US to maintain lower tariff rates on China imports for 90 more days (MedTech Dive)
- New Advisory Group To Shape UK’s Simplified Informed Consent Process (Pink Sheet)
- China-based Kangji Medical gets $1.4 billion go-private offer (Reuters)
- Alnylam could be the next mega-cap biotech (STAT)
- Pfizer drug extends survival for some bladder cancer patients (STAT)
- Bayer adds cancer drug candidate to portfolio with $1.3-billion Kumquat deal (Reuters)
- ICHRA collides with an increasingly unstable individual market (Endpoints)
- Biohaven scraps Phase 3 OCD program; Fosun’s licensing deal with Expedition (Endpoints)
- BlinkRx offers launch support to new pharma DTC programs (Fierce Pharma)
- Summit skips quarterly investor call as deal rumors swirl (Fierce Pharma)
- Argenx serves up Seles collab for myasthenia gravis awareness (Fierce Pharma)
- Generative AI tools for doctors consolidate as Doximity acquires Pathway (STAT)
- Abridge adds live prior authorization to its AI scribe with Highmark Health (STAT)
- Fertility Startup Gameto Raises $44 Million to Test Egg-Freezing Therapy in US (Bloomberg)
- Heartflow’s IPO raises $364M (MedTech Dive)
- SetPoint Medical secures $140M to fund neuromodulation for arthritis (MedTech Dive)
- BD Sees $90M Tariff Hit In Q4; 2026 Impact Reduced To $275M (MedTech Insight)
- Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database (MedTech Insight)
- MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User Fees (FDA Law Blog)
- A 'Farm Babe' fights for GMOs and Big Ag, pushing back on MAHA influencers (Reuters)
- Snickers maker Mars to use gene-editing in pursuit of stable chocolate supply (Food Dive)
- CDC staff voice fears about agency’s security vulnerabilities in internal calls (STAT)
- Keeping pregnant participants out of medical research is more dangerous than including them (STAT)
- Scientific panel puts new guardrails around stem cell-based embryo models (STAT)
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