FDA granted a Breakthrough Therapy designation to abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive advanced or metastatic breast cancer.
MD Anderson Cancer Center and Theraclone Sciences launched OncoResponse, an immuno-oncology antibody discovery company.
FDA granted Priority Review for defibrotide for the treatment of patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with evidence of multi-organ dysfunction following hematopoietic stem-cell transplantation.
The European Medicines Agency Committee for Medicinal Products for Human Use delivered two positive opinions, recommending marketing authorization for Kyprolis and Blincyto.
FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced non-small cell lung cancer whose disease has progressed after other treatments and with tumors that express the protein PD-L1.
City of Hope and Sorrento Therapeutics Inc. formed a company, LA Cell Inc., to focus on the development of cell-penetrating antibody therapies. LA Cell has exclusively licensed technology developed at City of Hope that enables modified monoclonal antibodies to penetrate into cells and target disease-causing molecules.
UbiVac formed a collaboration with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop new preclinical and clinical versions of UbiVac's proprietary DRibble immunotherapy for use in preclinical studies of oral cancer.
Aspen Park Pharmaceuticals Inc. acquired worldwide rights to APP-111, first-in-class oral, antitubulin targeting agent for the potential treatment for the form of castration resistant prostate cancer, from The Ohio State University, through the Ohio State Innovation Foundation.
FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting.
FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting.
