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pharmanewsdaily

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Gan & Lee gets FDA orphan drug status for GLR2007 in malignant glioma

Gan & Lee Pharmaceuticals has been given orphan drug designation from the US Food and Drug Administration (FDA) for GLR2007 for the treatment of malignant glioma, an aggressive primary brain tumor. According to the Chinese biopharma company, GLR2007 is an inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6), which is being developed for the treatment of […]
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Takeda’s NINLARO fails to meet PFS primary endpoint in TOURMALINE-MM2 trial

Takeda Pharmaceutical said that the Phase 3 TOURMALINE-MM2 trial in newly diagnosed multiple myeloma patients for NINLARO (ixazomib) in addition to lenalidomide and dexamethasone failed to meet the primary endpoint of progression-free survival (PFS). The late-stage trial assessed the combination of NINLARO (ixazomib) with lenalidomide and dexamethasone in comparison to lenalidomide and dexamethasone plus placebo […]