Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
AstraZeneca AZN and partner Merck MRK announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.
European regulators have issued a green light for Amgen and Allergan’s Mvasi, marking the first biosimilar of Roche’s Avastin to be approved in the region. The drug has been cleared to treat a range of indications spanning carcinoma of the colon or rectum, breast cancer; nonsquamous non-small cell lung cancer, renal cell cancer; platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. The companies noted that the approval came after trial data showed a high degree of similarity between Mvasi (biosimilar bevacizumab) and its reference drug, “with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products”. Mvasi is the first product borne out of an alliance between Amgen and Allergan to bag marketing authorisation from the European Commission, “highlighting the success of our joint commitment to developing cancer biosimilars,” noted David Nicholson, chief research and development officer at ...
Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development in recurrent Head and Neck Cancer, including Fast Track designation granted by the FDA, initiation of clinical studies in Japan, and plans to start pivotal studies, which will incorporate the evaluation of anti-cancer immune responses, in early 2018.
Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
NHS officials have surmised that a system that identifies seriously ill patients would save approximately 2,000 lives a year. They have also estimated that 627,000 ‘bed days’ could be saved as a result.
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