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October 27, 2025
by Jason Scott

Recon: Novartis to buy RNA developer Avidity in $12B deal; Intellia halts gene therapy trials following patient liver injury

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Generic drugmakers seek to thwart a Connecticut law that would cap rising prices (STAT)
  • Novartis to buy RNA-focused Avidity in $12 billion deal (STAT)
  • J&J Talc Cancer Suits Rise 17% After Failed Settlement Effort (Bloomberg)
  • CMS calls back furloughed employees to help with Medicare, ACA enrollment periods (MedTech Dive)
  • Merck nabs updated FDA label for PAH med Winrevair (Fierce Pharma)
In Focus: International                                                                                                       
  • Chinese biotech industry shows no signs of slowing as threat of U.S. restrictions loom (STAT)
  • Exclusive: Scottish microRNA startup claims signs of success in Phase 2 tendinopathy study (Endpoints)
  • India advances anti-dumping probe into tuberculosis drug imports from China, Thailand (Reuters)
  • Reworked German Hospital Reform Law Expected Q1 2026 After Critics Get Heard (MedTech Insight)
  • Danaher Says China VBP Impact Now ‘Modest and Manageable’ As Diagnostic Headwinds Ease (MedTech Insight)
  • UK Medtechs On A Journey To MARRS Find Welcome Regulatory Funding Support (MedTech Insight)
  • UK watchdog slams AstraZeneca, Organon for marketing breaches (Fierce Pharma)
Pharma & Biotech
  • All of a sudden, dementia treatment is becoming very exciting (STAT)
  • Intellia pauses two late-stage CRISPR gene-editing trials after emergence of safety concern (STAT)
  • CAR-T therapies from Cabaletta, Bristol Myers Squibb induce remissions in patients with autoimmune disorders (STAT)
  • BridgeBio study data on drug for rare form of muscular dystrophy could set up approval (STAT)
  • Zenas’ multiple sclerosis drug slows new brain lesions in mid-stage trial (Endpoints)
  • FDA approves Syndax’s menin inhibitor with black-box warning; GSK’s ADC deal (Endpoints)
  • BridgeBio shifts filing plans for rare disease drug after Phase 3 success (Endpoints)
  • Neumora moves forward with NLRP3 in obesity after Ventyx's drug failed to deliver weight loss (Endpoints)
  • Hemab nabs $157M to finance the 'ultimate coagulation disorder' biotech (Endpoints)
  • Novo-backed MapLight valued at $787 million after shares jump in Nasdaq debut (Reuters)
  • Organon CEO Kevin Ali to resign after probe into contraceptive sales (Reuters)
Medtech
  • WuXi AppTec to divest clinical services to focus on manufacturing business (Endpoints)
  • Revvity lifts profit forecast on renewed demand in diagnostics unit (Reuters)
  • Corcym, CardioPrecision set sights on robotic heart valve replacement (MedTech Dive)
  • J&J awards first grants from AI surgery fund (MedTech Dive)
  • Medtech industry closely watching Section 232 investigation (MedTech Dive)
  • Accuray hires Steve La Neve as CEO in transformation effort (MedTech Dive)
Food & Nutrition
  • Food giants may lean more on lawsuits as private label encroaches on their turf (Food Dive)
  • Food industry prepares to fight MAHA in states (Food Dive)
Government, Regulatory & Legal  
  • ‘From Diagnostics To Prognostics’: Google Cloud Healthcare Director Sees AI As Healthcare’s Future (MedTech Insight)
  • Could Oura Take A Bite Out Of Apple? Company Seeks FDA Clearance For Blood Pressure Feature (MedTech Insight)
  • Trump offers new warning on Tylenol for pregnant women (The Hill)
  • Why new mpox cases in California are raising concerns (The Hill)
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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