Kyowa Awaits EU Decision On Drug For Treating Parkinson’s ‘Off’ Time
Cancer Prevention Pharma Wants A Re-Examination Of Negative Opinion On Flynpovi
The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.
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EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma
A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Sanofi, Regeneron Seek Fast-Track Reviews From EMA
EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.