FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde. The effectiveness of Onivyde was demonstrated in a phase III, three-arm, randomized, open label study of... […]
FDA granted Priority Review to MCNA, developed by Telesta, for the treatment of high-risk, non-muscle invasive bladder cancer patients who are refractory or relapsing from BCG front-line treatment.
Imbruvica was awarded the prestigious Prix Galien 2015 Award for Best Pharmaceutical Agent.
FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
FDA granted de novo clearance to SonaCare Medical LLC to market the Sonablate 450 in the U.S. for the ablation of prostate tissue.
FDA approved Yondelis (trabectedin) for the treatment of liposarcoma and leiomyosarcoma that cannot be removed by surgery or is metastatic. This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency previously granted Priority Review and orphan drug designations for Onivyde.
Sequenom Inc. entered into a clinical collaboration with University Medical Center Hamburg-Eppendorf in Germany. They will collaborate to profile circulating cell-free tumor DNA in blood to monitor response to treatment in later stage colorectal cancer patients.
Eli Lilly and Co. and Innovent Biologics Inc. expanded their drug development collaboration to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
The Ontario Institute for Cancer Research and Novera Therapeutics Inc. will collaborate with Janssen Biotech, a pharmaceutical company of Johnson & Johnson, to develop small molecule drug candidates for hematological cancers.
