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)
- 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)
- 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)
- 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)
- 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)
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