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March 3, 2025
by Jason Scott

Recon: House Democrats question RFK Jr. over health agency firings; EMA reaffirms positive recommendation for Alzheimer’s drug Leqembi

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

In Focus: US
  • US health agency now says employees must respond to DOGE email (Reuters)
  • Former director Francis Collins retires from NIH, urging ‘respect’ for embattled workers (STAT)
  • Medicare and Medicaid agency faces compromised functions and disruption from Trump’s firings (STAT)
  • US House Democrats press Kennedy over health agency firings (Reuters)
  • US Health Secretary Kennedy calls for end to deadly Texas measles outbreak (Reuters)
  • At least seven drugmakers say they will participate in round two of IRA negotiations (Endpoints)
  • Bipartisan 'pill penalty' fix and other bills vie for inclusion in reconciliation package (Endpoints)
  • Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years (MedTech Insight)
  • US FDA issues labeling changes for testosterone products (Reuters)
In Focus: International                                                                                                       
  • We tried to quantify the impact of abrupt PEPFAR cuts. The results startled even us (STAT)
  • U.S. actions may set polio eradication back, WHO says (Reuters)
  • EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug (Reuters)
  • India's Sun Pharma aims to launch its obesity drug in five years, managing director says (Reuters)
  • Uganda reports second Ebola death, a 4-year-old, WHO says (Reuters)
  • ICER finds GSK inhalers offer advantages over generic competitors (Endpoints)
  • CHMP recommends Regeneron, Novartis drugs that still await FDA approval (Endpoints)
  • Prostate Cancer Research Urges UK To Implement Screening Program Without Delay (MedTech Insight)
Pharma & Biotech
  • AbbVie steps into the obesity drug race, licensing medicine from Danish firm (STAT)
  • After Phase 3 depression setback, Neumora pauses two trials to make changes, scraps another (Endpoints)
  • ADCs from a decade-old Singapore biotech find new life with $187M (Endpoints)
  • Lexicon plots Phase 3 trial for diabetic pain drug despite mid-stage flop (Endpoints)
  • Novo Nordisk signs $354M partnership with AI-guided biotech for ‘risky’ new metabolic mechanisms (Endpoints)
  • African drugmaker Aspen says new Latam and Eli Lilly portfolio boosting earnings (Reuters)
  • Aspen Surges as It Sees Own Diabetes, Obesity Drug Sales by 2026 (Bloomberg)
Medtech
  • Illumina to lay off 96 San Diego employees (MedTech Dive)
  • Medtronic partners with Brainomix on AI stroke tool (MedTech Dive)
  • Court Decision On LDTs ‘Quite Realistic’ Before May Deadline, Says ACLA Attorney (MedTech Insight)
  • Review: Oura’s Ring 4 Leads the Emerging Smart Ring Market (Bloomberg)
Government, Regulatory & Legal
  • DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule (Pink Sheet)
  • US FDA’s March Approval Candidates Take Aim At Established Markets (Pink Sheet)
  • Sponsors Increasingly Happy With CBER Written Responses To Formal Meeting Requests (Pink Sheet)
  • EU Urged To Prioritize Clinical Strategy Talks In Pre-Submission Process (MedTech Insight)
  • EMA Makes It Easier To Discover Ongoing Studies With New Clinical Trials Map (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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