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GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

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.

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UniQure/CSL Set To Launch First Hemophilia B Gene Therapy Next Year At Record Price

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.

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Asia Deal Watch: Eisai Advances Portfolio Focus With Divestiture Of Two Products To DKSH

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BioMarin Prepares Investors For A Possible US Hemophilia Gene Therapy Delay

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.

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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Macromolecule
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Genetix Pharmaceuticals
    • Precision Genome Engineering, Inc. (Pregenen)
    • Oncology Newco
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