REGENERON PHARMACEUTICALS INC. and Adicet Bio Inc. announced a collaboration and licensing agreement to develop next-generation engineered immune cell therapeutics. The companies plan to engineer immune cells with fully human chimeric antigen receptors (CARs) and T-cell receptors (TCRs) directed to disease-specific cell surface antigens in order to enable the precise engagement and killing of tumor... […]
METAMARK GENETICS INC. said that Palmetto GBA issued final local coverage determination for ProMark, a proteomic prognostic test for early-stage prostate cancer. The finalized ProMark LCD is effective Oct. 10, 2016, and approves Medicare reimbursement coverage for eligible prostate cancer patients to help determine which patients can be conservatively managed rather than treated with definitive... […]
BTG INTERNATIONAL CANADA INC., part of the global specialist healthcare company BTG, said that it received approval from Health Canada for DC Bead LUMI a radiopaque drug-eluting bead called DC Bead that can be loaded with doxorubicin or irinotecan for the local treatment of tumours in patients with hepatocellular carcinoma (HCC) and malignant colorectal cancer... […]
MYLAN N.V. and Biocon LTD said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics and confirmatory efficacy/safety global clinical trials for... […]
CUMBERLAND PHARMACEUTICALS INC. will begin distributing Ethyol (amifostine) for injection to U.S. wholesalers. Ethyol is an FDA approved cytoprotective drug indicated to reduce the incidence of xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with... […]
ARRAY BIOPHARMA said FDA accepted its New Drug Application for binimetinib with a target action date under the Prescription Drug User Fee Act of June 30, 2017. Array completed its NDA submission of binimetinib in late Jun. 2016 based on findings from the phase III NEMO trial in patients with NRAS-mutant melanoma. jQuery(document).ready(function(){ jQuery('.people-thumb +... […]
IBM and Hangzhou CognitiveCare said 21 hospitals across China will adopt Watson for Oncology trained by Memorial Sloan Kettering, a cognitive computing platform for physicians to help them deliver personalized, evidence-based cancer treatment options. The initial 21-hospital introduction is part of a far-reaching, multi-year partnership through which Hangzhou CognitiveCare will introduce Watson for Oncology to hospitals across China. This is Watson Health's first partnership in China.
THE DEPARTMENT OF PATHOLOGY at the Icahn School of Medicine at Mount Sinai established the Center for Computational and Systems Pathology to use computer science and mathematical techniques coupled with microscope technology and artificial intelligence to change pathology practice. The goal of this new academic research facility is to explore efforts to more accurately classify... […]
NOVARTIS said FDA has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.
JANSSEN BIOTECH Inc. submitted a supplemental Biologics License Application for daratumumab (Darzalex) to FDA. The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one... […]
