APOTEX Corp. has launched imatinib mesylate tablets, the generic equivalent of Gleevec by Novartis. Apotex’s Imatinib Mesylate Tablets are now available in 100mg and 400mg strengths. According to IMS Health, Gleevec had approximately $2.4 billion in sales in the 12 months ending in May 2016. jQuery(document).ready(function(){ jQuery('.people-thumb + p > span.has-red-100-color, .people-thumb + p >... […]
BIOLINERX LTD. announced the signing of a collaboration agreement with MD Anderson Cancer Center for the investigation of BL-8040 in combination with Keytruda (pembrolizumab) in pancreatic cancer. The study will be conducted as an investigator-sponsored study, as part of a strategic clinical research collaboration between MSD (known as Merck in the US and Canada) and... […]
EXACT SCIENCES Corp. said the Centers for Medicare and Medicaid Services issued an updated Evidence of Coverage notice for Medicare Advantage plans that affirms such plans must include coverage of Cologuard every three years without patient coinsurance, copayments or deductibles. “The CMS update assures patients and physicians that Cologuard is covered by Medicare Advantage plans... […]
Cellectar Biosciences Inc. received the second phase of an NCI Fast-Track Small Business Innovation Research contract award of $2 million to support funding of a phase II study of the company’s lead product candidate, CLR 131, for the potential treatment of hematologic malignancies, including multiple myeloma. The award will help fund a multi-center, open label […]
Advanced Accelerator Applications and NCI formed a clinical trial agreement: NCI plans to sponsor and conduct a study of Lutathera in patients with inoperable pheochromocytoma and paraganglioma. Pheochromocytoma is a rare endocrine tumor originating in the adrenal glands. Paraganglioma is a tumor that is closely related to pheochromocytoma and originates from outside the adrenal glands. […]
FDA and the Centers for Medicare and Medicaid Services have accepted the FoundationOne comprehensive genomic profiling assay for parallel review. FDA also accepted Foundation Medicine’s request for review as part of its Expedited Access Pathway for breakthrough devices. If approved, the assay would be the first to incorporate multiple companion diagnostics to support precision medicine […]
FDA 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 advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.
FDA approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with the drug ribavirin.
Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency accepted a Marketing Authorization Application for Pegfilgrastim, a proposed biosimilar for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes. In... […]
The European Medicines Agency granted a PRIority MEdicines, or PRIME, designation for DNX-2401 as a treatment for recurrent glioblastoma. The PRIME designation was launched by the EMA in March to accelerate the regulatory approval of breakthrough therapies that target an unmet medical need. The objective is to provide patients who have few treatment options with... […]
