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News Breaks
July 7, 2014
13:36 EDTNVONovo Nordisk says FDA approves NovoSeven RT for treatment of GT
Novo Nordisk announced the FDA has approved NovoSeven RT as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's Thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets. Glanzmann's Thrombasthenia is a rare genetic bleeding disorder with limited treatment options. The safety and effectiveness of NovoSeven RT were demonstrated in the treatment of severe bleeding episodes and the perioperative management for major and minor surgical procedures for this specific patient population. The FDA approved NovoSeven RT for the treatment of GT based upon evidence collected from the global Glanzmann's Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry The data supported the effectiveness and safety of NovoSeven RT in the treatment of bleeding and for the prevention of bleeding during surgical procedures in patients with GT.
News For NVO From The Last 14 Days
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March 2, 2015
08:53 EDTNVONon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
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February 26, 2015
18:44 EDTNVONovo Nordisk receives Health Canada approval for Saxenda
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February 20, 2015
12:02 EDTNVOEmisphere says Novo Nordisk completes Phase 2 OG217SC trial
Emisphere Technologies (EMIS) highlighted positive Phase 2 data from Eligen licensee Novo Nordisk (NVO) pertaining to OG217SC, the oral formulation of semaglutide, a long-acting human GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. OG217SC is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is included in the Eligen Carrier Concept. Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks. Results of the study are available on Novo Nordisk's website. Based on these results, Novo Nordisk announced that it will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made. Under its GLP-1 License Agreement, Novo Nordisk is working to develop and commercialize oral formulations of its proprietary GLP-1 receptor agonists in combination with Emisphere carriers. Under the GLP-1 License Agreement, Emisphere could receive additional contingent product development and sales milestone payments and would also be entitled to receive royalties in the event Novo Nordisk commercializes products developed under such Agreement. Under the GLP-1 License Agreement, Novo Nordisk is responsible for the development and commercialization of the products.

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