1. Pink Sheet

EU Accelerated Assessment – Hard To Get, Hard To Keep

 
• By Maureen Kenny

It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.

Hot air balloons
Fast-track review can give companies an important competitive advantage

Many of the marketing authorization applications (MAAs) that until recently were being evaluated under the European Medicines Agency’s accelerated assessment mechanism have reverted to standard review timelines. The MAAs relate to products such as AveXis’s gene therapy, Zolgensma, and several other products that, like Zolgensma, have already been approved in the US.

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