Otsuka subsidiary Astex plans filing in MDS by year-end for first oral decitabine product on the back of positive Phase III comparative results.
Otsuka Pharmaceutical Co. Ltd. subsidiary Astex Pharmaceuticals Inc. plans to file for the US approval of ASTX727, an oral fixed-dose combination of decitabine and cedazuridine, by the end of this year, after the product met its primary endpoint in a Phase III trial.
The positive top-line results came from the 138-patient, open-label ASCERTAIN study in North America with the combo versus intravenous decitabine,...
The FDA eliminated REMS requirements for approved CAR-T cell therapies that have limited their availability, a move that could enable increased use in the community setting.
Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.
Deal Snapshot: The biotech will receive up to $750m from Gilead for molecular glue degraders against CDK2.
Zidesamtinib would be the fifth ROS-1 targeting therapy on the market, but Nuvalent believes its safety and efficacy profile will make it the best in class.
