The European Medicines Agency granted an Orphan Drug Designation to ENMD-2076, developed by CASI Pharmaceuticals Inc., for the treatment of hepatocellular carcinoma, including fibrolamellar carcinoma, a rare type of HCC.
MedImmune joined the Human Vaccines Project, a public-private partnership seeking to develop new vaccines and immunotherapies.
FDA approved Opdivo (nivolumab) to treat patients with non-squamous, advanced non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
FDA granted orphan drug designation to drug candidate BLU-554 for the treatment of hepatocellular carcinoma.
Immunovia AB and the Knight Cancer Institute at Oregon Health & Science University formed a collaboration to confirm, validate and commercialize a blood test for the early diagnosis of pancreatic cancer.
Merck and Bionomics Limited extended their strategic collaboration for the discovery and development of drug candidates for the treatment of chronic and neuropathic pain.
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.
