Pharma News

Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

Novartis announced positive results from the first large-scale study exploring the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate COPD from their current treatments, including steroid-containing combinations and long-acting bronchodilators, to the dual bronchodilator Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg.

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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.

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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.

Theravance Biopharma, Inc. announced that GlaxoSmithKline plc (GSK) and Innoviva, Inc. (Innoviva) have filed a Marketing Authorization Application (MAA) in the European Union for the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA® inhaler) for patients with chronic obstructive pulmonary disease (COPD). 

AstraZeneca  presented data from the AURA3 trial that data is supportive of Tagrisso (osimertinib) potentially becoming the new standard of care for 2nd-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC). The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine.