1. Pink Sheet
  2. >>Pathways & Standards

Moderna & Merck’s mRNA Cancer Vaccine Secures EMA PRIME Designation

 
• By Neena Brizmohun

A total of four investigational products targeting unmet medical needs have made it onto the European Medicines Agency’s priority medicines scheme so far this year.

Thumbs up
New applications for entry onto the PRIME scheme get the thumbs up • Source: Shutterstock

Moderna, Inc. and Merck & Co., Inc.'s* investigational personalized mRNA cancer vaccine, mRNA-4157/V940, has secured a place on the European Medicines Agency’s PRIME (priority medicines) scheme, for use in combination with Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.

The PRIME designation for the therapy “highlights the potential promise of individualized cancer treatments in a population with limited alternatives,"...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Review Pathways

More from Pathways & Standards

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.