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June 3, 2025
by Jason Scott

Recon: Wegovy use up 50% among US teens; Hims to acquire UK-based telehealth firm Zava

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

In Focus: US
  • Wegovy use among US teens up 50% as obesity crisis worsens (Reuters)
  • New HHS document details deep NIH cuts as part of Trump budget request (STAT) (The Hill) (MedtechDive)
  • HHS has a new national health IT coordinator (STAT)
  • Q&A: Sandoz CEO Richard Saynor on generic GLP-1s, Trump's industry impact, and Mark Cuban's company (STAT)
  • FDA's 2026 budget plan seeks to shrink overall funds, but increase user fees (Endpoints)
  • DOGE set today as their last day at FDA. Instead, they're continuing to get full pay and don't work (Endpoints)
  • The MAHA Report’s Errors Are Just the Start of Its Problems (Bloomberg)
In Focus: International  
  • Hims to acquire UK-based startup Zava as it expands international presence (Reuters)
  • US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe (Pink Sheet)
  • Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers (Pink Sheet)
  • China NMPA Lays Out Regulatory Priorities At DIA (Pink Sheet)
  • China Criticizes EU’s Planned Curb on Medical Device Procurement (Bloomberg)
  • The US slashed HIV/AIDS funding. Here is how countries that relied on it might adapt (STAT)
Pharma & Biotech
  • Novartis' Pluvicto shown to slow prostate cancer in earlier setting (Reuters)
  • BioNTech presents impressive early data for PD-L1xVEGF in mesothelioma (Endpoints)
  • At ASCO, cell therapies for deadly form of brain cancer make early strides (Endpoints)
  • Vera redraws the terms of up to $500M credit facility; Trevi aims to raise $100M (Endpoints)
  • Lyra’s stock soars on Phase 3 success for chronic rhinosinusitis treatment (Endpoints)
  • Regeneron makes $80M obesity deal with Hansoh (Endpoints)
Medtech
  • 23andMe founder aims to restart auction with major corporate backing (Reuters)
  • MAHA kids’ health report misinforms about tonsillectomies and ear tubes (STAT)
  • Canid raises $10M to manage vaccines for pediatricians (Endpoints)
  • Nvidia’s David Niewolny on the future of AI in medical devices (MedTech Dive)
  • Beta Bionics CEO, CFO on how to take a company public (MedTech Dive)
  • First AI Breast Cancer Prediction Platform Receives FDA Authorization (MedTech Insight)
  • FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny? (FDA Law Blog)
Food & Nutrition Government, Regulatory & Legal
  • Ingredient up to 13,000 times sweeter than sugar lurks in vapes popular with teens, study shows (STAT)
  • Pyx Health buys FarmboxRx to reach more Medicaid and Medicare members (Endpoints)
  • Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule (MedTech Insight)
  • US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs (Pink Sheet)
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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