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Latest From bluebird bio
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
The firms’ gene therapy Hemgenix has won a US thumbs up for the treatment of hemophilia B and plans are underway for a US launch with a big price tag that experts agree should pay off in the long-term.
Plus deals involving Dong-A/Polifarma, Intas/Syna, Kissei/Synmosa, Ono/Memo, Takeda/Shionogi, Fosun/Lilly and JW Therapeutics/2seventy bio.
FDA review of the company's BLA for a hemophilia gene therapy could be delayed by three months to allow the agency to review a three-year data analysis from an ongoing trial.
- Drug Delivery
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Genetix Pharmaceuticals
- Precision Genome Engineering, Inc. (Pregenen)
- Oncology Newco