The European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, granted orphan drug designation to synthetic hypericin, the active pharmaceutical ingredient in SGX301, for the treatment of cutaneous T-cell lymphoma, a rare disease and a class of non-Hodgkin's lymphoma.
Health Canada issued a Notice of Compliance with Conditions for Imbruvica (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma.
FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.
FDA granted a Breakthrough Therapy Designation to Lenvima (lenvatinib) in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor-targeted therapy.
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is based on data from the global ENDEAVOR trial. ENDEAVOR is the first of two head-to-head... […]
FDA granted an Orphan Drug Designation to Anisina (ATM-3507) for neuroblastoma. Anisina is developed by Novogen Ltd.
FDA approved Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Kyprolis is sponsored by Onyx Pharmaceuticals Inc., an Amgen subsidiary.
FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.
IriSys LLC was awarded a five-year contract worth up to $3 million by the NCI Developmental Therapeutic Program of the Division of Cancer Treatment and Diagnosis for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI. Under this agreement, IriSys will be supplying NCI with oral, topical... […]
FDA granted priority review to MM-398 in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
