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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.
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.
Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
A significant number of gene therapies are expected to come to market imminently, potentially revolutionizing health care systems. Developers will face significant clinical, regulatory and logistical challenges in bringing these therapies to market. Manufacturers and payers must work through the associated administrative, logistical and legal challenges in partnership.
- Drug Delivery
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)