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June 24, 2025
by Jason Scott

Recon: Makary reportedly sought CRL for KalVista drug; Novo launches Wegovy in India

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

In Focus: US
  • FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say (Endpoints)
  • A grim milestone: U.S. is on the cusp of losing its official measles elimination status (STAT)
  • Cassidy calls to delay meeting of CDC’s vaccine panel in challenge to RFK Jr. (STAT)
  • Capricor says US FDA may not convene expert panel for co's cell therapy (Reuters)
  • US health secretary Kennedy says he brought back 722 CDC employees, 220 at NIH (Reuters)
  • Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy (Pink Sheet)
  • US CDC report shows no link between thimerosal-containing vaccines and autism (Reuters)
  • Cigna sues Bristol Myers for alleged monopoly over blockbuster cancer drug (Reuters)
In Focus: International
  • Novo Nordisk launches weight-loss drug Wegovy in India to compete with Lilly's Mounjaro (Reuters)
  • Gates Foundation to commit $1.6 billion for Gavi vaccine alliance (Reuters)
  • EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment (Pink Sheet)
  • New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico (Pink Sheet)
  • UK government blueprints ambition to be a key life sciences hub  (Endpoints)
  • £2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector (MedTech Insight)
  • Home-Testing Added To UK National Cervical Cancer Screening Program (MedTech Insight)
  • Amarin sells Vascepa's rights in Europe to Recordati for $25M (Fierce Pharma)
Pharma & Biotech
  • Nuvalent says its ROS1-targeted drug shrank lung tumors in patients who failed other options (STAT)
  • GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight (STAT)
  • Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing (STAT)
  • Nektar's mid-stage eczema data deliver key win in bid for company turnaround (Endpoints)
  • ArriVent plots next steps for lung cancer drug; Neuron23's $96.5M raise (Endpoints)
  • AstraZeneca, Daiichi Sankyo gain lung cancer indication for Enhertu successor (Endpoints)
  • Roche plans to pit next-gen hemophilia A antibody against Hemlibra in Phase 3 (Endpoints)
  • Exelixis' positive Phase 3 colorectal cancer data boost stock (Endpoints)
  • Royalty Pharma to pay up to $2 billion to Revolution Medicines for cancer drug (Reuters)
  • Craig Romanok takes up chief commercial officer post at Digitas (Fierce Pharma)
Medtech
  • Device that uses biodegradable polymers to repair peripheral nerves gets FDA clearance (STAT)
  • From boom to bitcoin: A device maker’s surprising pivot amid a Medicare crackdown (STAT)
  • Why this health tech investor thinks AI could bring the ‘learning health system’ to life (STAT)
  • Illumina to buy SomaLogic for up to $425M (MedTech Dive)
  • ADA takeaways: Diabetes tech firms preview new patch pumps, glucose sensors (MedTech Dive)
  • GE Healthcare recalls Carestation devices over ventilation failure risk (MedTech Dive)
  • New Openwater Data Shows Promise For AI-Driven Optical Rapid Stroke Detection (MedTech Insight)
Food & Nutrition
  • Texas Governor Abbott Signs MAHA-Similar Bill into Law (Food Safety)
  • David responds to lawsuit, denies hoarding ingredient (Food Business News)
Government, Regulatory & Legal
  • US health secretary Kennedy says he brought back 722 CDC employees, 220 at NIH (Reuters)
  • Health insurers promise to reduce barriers to care under pressure from Trump administration (STAT)
  • The Senate’s version of Trump’s tax-cut bill threatens safety-net hospitals like ours (STAT)
  • Balkanization of vaccine policy raises concerns about vaccine uptake, insurance coverage, experts warn (STAT)
  • Supreme Court asks DOJ to weigh in on Hikma ‘skinny label’ fight against (Endpoints)
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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