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February 11, 2025
by Jason Scott

Recon: Germany’s Merck in talks to acquire SpringWorks; Judge orders FDA, CDC to restore deleted portions websites

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

In Focus: US
  • Trump administration ordered to restore removed CDC and FDA websites (Reuters)
  • Halt on Trump administration’s cuts to NIH research payments expanded nationwide (STAT)
  • Key GOP senators push back against NIH funding cuts (STAT)
  • How RFK Jr. could revive a dormant task force to scrutinize vaccine safety (STAT)
  • CVS Health's turnaround efforts in focus amid record-high medical costs (Reuters)
  • Insurer Humana forecasts 2025 profit below estimates, expects drop in membership (Reuters)
  • FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived (FDA Law Blog)
In Focus: International                                                                                                       
  • Germany's Merck in advanced talks to acquire US biotech firm SpringWorks (Reuters)
  • Number of confirmed Ebola cases in Uganda rises to nine (Reuters)
  • Updated EU Guidance Reinforces How Notified Bodies Should Use Existing Evidence (MedTech Insight)
  • Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma (Pink Sheet)
  • Depemokimab & Tzield Among 10 New EU Filings (Pink Sheet)
Pharma & Biotech
  • How the ‘amyloid mafia’ took over Alzheimer’s research (STAT)
  • Vertex pain pill dominates earnings call discussion (STAT)
  • Novartis returns for its anticoagulant in up to $3.1B buy of Blackstone’s Anthos (Endpoints)
  • Inventiva cuts pipeline, lays off nearly entire research team in bid to get to Phase 3 MASH readout (Endpoints)
  • IN8bio’s Phase 1 AML data; Layoffs at Q32 Bio and Third Harmonic (Endpoints)
  • Pfizer’s prostate cancer data leak shows promising results in early-stage study (Endpoints)
  • Vertex operations chief Stuart Arbuckle to retire (Endpoints)
  • Eli Lilly inks $630M deal for Phase 1 MASH candidate (Endpoints)
  • Bayer brings heart health message to Super Bowl, warning millennials to open their eyes to risks (Fierce Pharma)
  • Pfizer wins 2025 Super Bowl with ad's 'likeability,' while Hims & Hers' spot takes engagement crown: analysts (Fierce Pharma)
  • Explainer: The Thriving Shadow Market of GLP-1s for Weight Loss (BioSpace)
Medtech
  • Former FDA head Gottlieb calls for less regulation of certain AI tools (MedTech Dive)
  • Meta Rally Makes History as It Goes on Offensive With AI (Bloomberg)
  • Navigating the Unknown: EU HTA Regulation’s Impact on Commercial Confidentiality (Pink Sheet)
  • Vance Warns U.S. Allies to Keep AI Regulation Light (The Wall Street Journal)
Government, Regulatory & Legal
  • Mass General Brigham announces largest layoff in its history amid ongoing restructuring (STAT)
  • A check-in on health insurers’ medical costs, and more babies are being born (STAT)
  • Stopgap measures against H5N1 bird flu can only go so far (STAT)
  • Trump’s tariff impact likely ‘minimal’ for brand-name drugmakers, manufacturing partners (Endpoints)
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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