EU Fast-Track Review In Store For Takeda’s Dengue Vaccine
Accelerated Assessment Also For New Therapies From Regeneron And Bluebird Bio
Executive Summary
Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.
You may also be interested in...
Communication Hurdles Remain For Sanofi’s Dengue Vaccine
CDC drafting recommendation for Sanofi’s Dengvaxia, setting parameters for required pre-vaccination screening in the absence of tests approved by the US FDA.
Takeda Looks To Ride 'Wave 1' To JPY5tn Target
Takeda tries to get investors as excited as it is about the first wave of post-R&D reorganization candidates coming through, as it lays out 'ambitious but achievable' revenue target.
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.