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August 28, 2025
by Jason Scott

Recon: FDA approves Teva’s generic obesity drug; Kennedy to testify on health agenda next week

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

In Focus: US
  • CDC Director Susan Monarez is ousted as her lawyers say ‘she will not resign’ (STAT)
  • GOP Health chair Bill Cassidy vows Senate oversight after CDC shake-up (The Hill)
  • Kennedy to testify before Senate panel on health agenda (Reuters)
  • RFK Jr. defends CDC shakeup after high-level resignations (The Hill)
  • CDC Vaccine Advisers Schedule September Meeting Amid Disarray (Bloomberg)
  • FDA issues narrower approvals for Covid boosters, revokes emergency authorizations (STAT)
  • Prasad explains why FDA revoked Pfizer's Covid vaccine EUA for children (Endpoints)
  • US FDA approves Teva Pharmaceuticals' generic obesity drug (Reuters)
  • US FDA declines to approve Outlook Therapeutics' drug for eye condition (Reuters)
In Focus: International                                                                                                       
  • The most burdensome diseases globally are the least studied, but the gap is narrowing (STAT)
  • NHS to lose out on new drugs, pharma firm warns (BBC)
  • UK approves GSK's antibiotic for female urinary tract infections (Reuters)
  • Drax Slumps on UK Probe Into Controversial Biomass Sourcing (Bloomberg)
  • Stada CEO Says IPO Planned This Year in Boost to European Market (Bloomberg)
  • Australia's Telix Pharma says FDA seeks more data on cancer diagnostic drug; shares plunge (Reuters)
Pharma & Biotech
  • FDA recommends more monitoring of Alzheimer's patients on Biogen's drug Leqembi (Reuters)
  • Illumina CEO sees path to stable growth, even as its academic customers face funding uncertainty (STAT)
  • An under-the-radar biotech finds FDA more receptive to an alternative to Covid vaccines (STAT)
  • Biopharma returns to MC4R for drugs targeting genetic obesity as well as appetite loss (Endpoints)
  • Prothena really wants a partner for its Phase 1 Alzheimer's program that reported high ARIA-E events (Endpoints)
  • REMS tweaks for Travere’s Filspari; AstraZeneca stops early-phase cardio study (Endpoints)
  • Stanford spinout raises $21.5M to turn cancer drivers against themselves (Endpoints)
  • Walgreens names new CEO and splits off Boots and other businesses as take-private deal closes (Endpoints)
  • Novo Nordisk seeks new obesity, diabetes drugs with Replicate BioScience partnership (Reuters)
  • Nvidia Forecast Is Looking Less Than Stellar (Bloomberg)
  • Maze Therapeutics referred to federal marketing regulators over challenge brought by Vertex (Fierce Pharma)
Medtech
  • Novo Nordisk links to telehealth providers for patients seeking Wegovy (STAT)
  • Epic’s ‘large medical model’ aims to change how hospitals predict patient risk (STAT)
  • Engage the community in generative AI for public health (STAT)
  • Why Twin Health is betting on 'digital twins' to tackle obesity (Endpoints)
  • Intuitive to lay off 331 employees in California (MedTech Dive)
  • Inspire CFO Rick Buchholz to step down at end of 2025 (MedTech Dive)
  • No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’ (MedTech Insight)
  • Qbeast Raises $7.6M To Tackle The Hidden Compute Tax In Open Data Lakehouses (MedTech Insight)
  • Reports Put $4B Price Tag On Versius Maker CMR. Will This Change Surgical Robot Valuation? (MedTech Insight)
Food & Nutrition
  • Baking association moves to eliminate FD&C colors in school food (Food Business News)
  • FDA identifies new Salmonella outbreak; reopens investigation into another (Food Safety News)
Government, Regulatory & Legal  
  • We surveyed hundreds of biomedical researchers about the instability in federal funding. Here’s what they said (STAT)
  • New report details the state of the biotech industry in Mass. The results are grim (STAT)
  • Health care giants are pushing hard for Congress to extend ACA insurance subsidies (STAT)
  • Walgreens Replaces CEO and Splits Up After Sycamore Acquisition (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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