Paclical received market authorization in the Russian Federation by the Russian Ministry of Health, and is planned for launch in the second half of 2015.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of malignant glioma.
FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.
Health Canada approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.
Immunocore Ltd. and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a second collaboration.
Bayer HealthCare expanded its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946), which now includes two new phase III studies in indolent non-Hodgkin's lymphomas and one additional phase II study in diffuse large B-cell lymphoma.
The European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI chemotherapy for the treatment of adult patients with wild-type RAS metastatic colorectal cancer.
Merck and Pfizer will begin co-promoting Xalkori in the U.S., Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the U.K.In the U.S. and Canada, Xalkori will be co-promoted by EMD Serono, the US and Canadian biopharmaceutical businesses of Merck.
Rubicon Genomics Inc. extended its clinical supply agreement with Agendia for use of its TransPLEX whole genome RNA amplification technology.
Intrexon Corp. signed a cooperative research and development agreement with NCI for the development of adoptive T cell therapies utilizing the RheoSwitch Therapeutic System platform for the treatment of solid tumor malignancies.