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  • Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xultophy® 100/3.6. Xultophy® 100/3.6 is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).

  • Janssen-Cilag International NV announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development of immune-mediated inflammatory diseases.

  • Eli Lilly and Company announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase 3 study of solanezumab in people with mild dementia due to Alzheimer's disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=.095), as measured by the ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale).

  • GlaxoSmithKline plc announced that both co-primary endpoints and all secondary endpoints were met in a pivotal phase III study investigating the efficacy and safety of mepolizumab, an IL-5 antagonist, in patients with relapsing and refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA), a rare disease characterised by widespread inflammation in the walls of small blood vessels (vasculitis).

  • GlaxoSmithKline plc and Innoviva, Inc. announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018.

  • GlaxoSmithKline plc announced the start of a phase III development programme investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anaemia associated with chronic kidney disease (CKD).
    The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to recombinant human erythropoietin

  • The Association of Indian Medical Device Industry (AiMeD) has applauded Govt’s move that comes in the wake of Finance Ministry urging RBI to undertake an audit of all investments made in medical device sector over policy loopholes and confusion over definitional distinction between medical device and pharma sector leading to increased vulnerability of Indian pharma companies and no real gains for domestic medical device manufacturing.

  • Allergan plc  announced the U.S. Food and Drug Administration (FDA) has cleared the XEN® Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The XEN Glaucoma Treatment System reduces intraocular pressure (IOP) in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. XEN is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.

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