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March 16, 2026
by Jason Scott

Recon: GSK nabs FDA authorization for expanded RSV jab indication; Mideast war disrupts region’s pharma supply chain

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • GSK’s RSV Shot Wins Expanded US Approval Amid Vaccine Pressure (Bloomberg)
  • Trump is getting more credit than Biden for efforts to lower drug prices (STAT)
  • PDUFA VIII: US FDA Shared Services Unit Could Reduce User Fees (Pink Sheet)
  • Genentech CEO says aiming for tolerable, affordable obesity drugs (Reuters)
In Focus: International
  • Middle East war disrupts pharma air routes, risks cancer drugs supply (Reuters)
  • Baidu-Backed BioMap Is Said to Confidentially File for HK IPO (Bloomberg)
  • Ozempic Patent Expiry Heralds Weight-Loss Drug Boom in India (Bloomberg)
  • Supply Costs Jump For India’s Medical Device Makers As Middle East Conflict Disrupts Gas Supply (MedTech Insight)
  • VBP, Reimbursement Cuts And Uncertain Outlook: How Medtech’s Biggest Players Are Reading China (MedTech Insight)
  • EU Push To Streamline Clinical Trials Must Respect Privacy Rights, Say Data Watchdogs (Pink Sheet)
  • French Health Care Professionals Warn Of Medicine Access Problems (Pink Sheet)
Pharma & Biotech
  • Novartis Offers High-Grade Debt to Fund $12 billion Avidity Deal (Bloomberg)
  • I have a genetic mutation linked to ALS. The Trump administration terrifies me (STAT)
  • Structure Therapeutics reports significant weight loss from mid-stage GLP-1 pill (STAT)
  • BioMarin pumps brakes on 3 Voxzogo studies as competition in drug's flagship achondroplasia indication mounts (Fierce Pharma)
Medtech
  • A brain-computer interface allowed people with paralysis to type with their mind (STAT)
  • Amplifon to Buy GN Store Nord Hearing Aid Unit for $2.6 Billion (Bloomberg)
  • Intuitive Surgical hit by phishing incident (MedTech Dive)
  • FDA Weight Loss Device Guidance Calls For Patient Focus (MedTech Insight)
  • FDA And Industry To Move Forward On Commitment Letter After Agreeing On Several Proposals (MedTech Insight)
Food & Nutrition
  • Japan Prices New Products Including Milk Fortifier But Cuts Capivasertib Price 10.7% (Pink Sheet)
  • USDA sued over state SNAP restrictions on candy, soda (Food Dive)
Government, Regulatory & Legal
  • New technologies promise to transform organ transplantation. But when? (STAT)
  • Major changes to cardiovascular guidelines suggest taking statins as young as 30 (STAT)
  • Congress must pass legislation to ensure Medicare covers breakthrough medical technologies (STAT)
  • FDA move on flavored vapes rattles public health experts (STAT)
  • Republicans Are Squandering Their MAHA Moment (Bloomberg)
  • Trump’s EPA Eases Controls in Proposed Ethylene Oxide Rule (Bloomberg)
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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