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)
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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.