• Takeda Pharma Pays $400M for Global Rights to Colorectal Cancer Drug

    12 days ago - By MedCity News

    The Hutchmed drug, fruquintinib, is already approved in China for colorectal cancer. Takeda Pharmaceutical gets global rights to the small molecule, which has started a rolling submission with the FDA and is being readied for regulatory submissions in Europe and Japan.
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  • STAT+: Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity

    STAT+: Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity

    12 days ago - By STAT

    In an unexpected move, the U.S. Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.
    Going forward, the agency will continue to confer seven years of marketing exclusivity for specific uses or indications for orphan drugs - the regulatory term for rare disease medicines - instead of allowing a drug company to win more expansive marketing rights, even if the medicine is only approved...
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