Thursday, December 3, 2015
Merck, of Darmstadt, Germany, and Pfizer have announced that the FDA has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen.
Viking Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, has submitted an investigational new drug (IND) application to FDA to conduct a phase II study of VK2809 in patients with hypercholesterolemia and fatty liver disease.
The FDA has granted Accelerated Approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) now is approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
Arxspan, a cloud-based solutions provider based in Massachusetts, has entered into an agreement with the Broad Institute of MIT and Harvard for use of its ArxLab cloud-based suite of biological and chemical discovery information management tools. The partnership will support the institute’s efforts to electronically manage and share both biological and chemical research information internally and with external collaborators. The ArxLab suite of tools will be used for managing the institute’s electronic laboratory notebook, compound and assay registration, scientific analysis and search, biological visualization, and inventory management functions.