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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.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
Among the six new investigational products to make it onto the European Medicines Agency’s priority medicines scheme, five were gene therapies.
Keeping Track: New Nucala Indication; BMS’ Ide-Cel Clears Filing Hurdle; First Applications From Telix And ADC Therapeutics
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
- Drug Delivery
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)