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August 12, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal  
  • 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)
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.
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