Viking Therapeutics, Inc. (Viking), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to VK0214 for the treatment of X-linked adrenoleukodystrophy (X-ALD).
Novartis announced results from its phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study, which found that patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months (95% confidence interval [CI]: 12.6, 27.2), compared to 8.1 months (95% CI: 5.8, 11.1) in patients treated with standard first-line chemotherapy with maintenance. This equated to a 45% reduction in the risk of disease progression (hazard ratio [HR] = 0.55, P<0.001).
Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted “Fast Track” status to IFN-alpha Kinoid in Lupus, the most advanced therapeutic vaccine issued from Neovacs R&D.
Kitov Pharmaceuticals Holdings Ltd. Announced that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration's (FDA) standards for establishing six months stability.
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