EMA PRIME Wins For Bispecific Antibodies & Another Gene Therapy
Just three of the 13 applications that the European Medicines Agency most recently reviewed for entry onto its priority medicines scheme made the grade.
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Janssen And Sanofi Keep Mum On EU Fast-Track Request Outcomes
Teclistamab and nirsevimab may or not be fast-tracked when their sponsors – Janssen-Cilag and Sanofi, respectively – file for pan-EU approval. In the meantime, a total of seven filings are currently benefiting from the accelerated assessment mechanism at the European Medicines Agency.
Janssen Wins EU Fast-Track Status For CAR-T Therapy Cilta-Cel
Three requests for the accelerated assessment of planned EU marketing applications were considered by the European Medicines Agency last month.
EMA Tells Companies How To Boost Their Approval Chances Under PRIME
Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.