Venetoclax was granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia in previously treated patients with the 17p deletion genetic mutation.
Member companies of the Pharmaceutical Research and Manufacturers of America invested an estimated $51.2 billion last year in the research and development of new innovative treatments and cures. The figure represents the majority of all biopharmaceutical R&D spending, both public and private, in the U.S.
DanDrit Biotech USA Inc. signed a collaboration agreement with GISCAD Foundation, an Italian group focused on cancers of the digestive tract.
Celgene International II Sàrl entered into a strategic collaboration with MedImmune Limited, a wholly owned subsidiary of AstraZeneca PLC, to develop and commercialize anti-PD-L1 inhibitor MEDI4736 for hematologic malignancies.
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.
