FDA granted an orphan drug designation for APTO-253 for the treatment of acute myeloid leukemia.
Merck Canada Inc. announced that Keytruda (pembrolizumab) was authorized for sale with conditions by Health Canada.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of malignant glioma.
The European Commission approved Aloxi (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in pediatric patients one month of age and older.
Halozyme Therapeutics Inc. and Ventana Medical Systems Inc., a member of the Roche Group, will collaborate and develop a Ventana companion diagnostic assay for use with Halozyme's investigational new drug PEGPH20.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for Imbruvica (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
FDA granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.
Baylor Research Institute and the Translational Genomics Research Institute extended a collaboration focused on accelerating early detection and treatments for patients with a broad range of cancers.
Palmetto GBA issued a draft local coverage determination for the Oncotype DX prostate cancer test developed by Genomic Health Inc. Palmetto is a Medicare Administrative Contractor that assesses molecular diagnostic technologies.
FDA granted a Fast Track Designation for evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. \
