EU Speedy Review Request For J&J’s Esketamine
J&J is hoping its experimental new drug for treatment-resistant depression will join the select group of products benefitting from speedy review in the EU.
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EU Accelerated Assessment Tracker: Rejection Is Standard Outcome For Fast-Track Requests This Year
Attempts by companies to have their investigational products fast-tracked through the EU approval system this year so far have largely failed. Often the same products have or had priority review in the US. With the European Medicines Agency deciding on four new accelerated assessment requests this week, will the tide start to turn?
Celgene, Agios Drug Enasidenib Among New Filings At EMA
Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.
A Massive First For EU – CAR-T Therapies Kymriah and Yescarta Hoping For CHMP OK
Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?