PRIME Time: Smaller Companies In Focus As EMA Launches Priority Medicines Scheme
This article was originally published in The Pink Sheet Daily
In exceptional cases, smaller and medium-sized companies might obtain PRIME designation in proof of principle stage, underscoring the expectation that they will particularly benefit from the program.
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The first four drugs European Medicines Agency selects for its new priority review program include Biogen's Alzheimer's disease treatment aducanumab. Fourteen applicants did not garner PRIME status.
Aside from pediatrics research issue, most of the first batch of applications for the new priority review scheme were "in scope," with numerous therapeutic areas targeted.
European Medicines Agency will try "just as hard" to aid companies who tap into other EU regulatory tools aimed at fostering quicker reviews, official says at BIA/MHRA conference.