Only One In Seven PRIME Applications Meets EMA Test
Executive Summary
Of the 14 applications for entry onto the European Medicines Agency’s priority medicines scheme during the first two months of 2019, only two – from AstraZeneca and Freeline – made the grade.
You may also be interested in...
Myeloma CAR T-Therapy Among New EMA PRIME Winners
Janssen, Krystal Biotech and Takeda are the latest companies to win a place on the European Medicines Agency’s popular priority medicines scheme for getting drugs for unmet medical needs through the review process faster.
Keeping Track: CDER Approves Its First Two Novel Agents Of 2019
The latest drug development news and highlights from our US FDA Performance Tracker.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.