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News Breaks
June 1, 2014
19:15 EDTNVSNovartis announces results of Phase 2 trial of LDE225
Novartis announced the results of a pivotal Phase II trial demonstrating that patients with locally advanced, or metastatic basal cell carcinoma taking the investigational oral compound LDE225, sonidegib, had marked and sustained tumor shrinkage after a median follow-up of 13.9 months.The data were revealed for the first time in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology, ASCO, in Chicago. "These results represent an important milestone in the clinical development of LDE225, as well as in our research strategy to develop new therapies for patients with unmet needs," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "These data will form the basis for the filing of another important new medicine for a skin-related disease in which Novartis is building a leading position." The data from this pivotal trial will serve as the basis for worldwide regulatory filings for the 200 mg dose of LDE225 in advanced basal cell carcinoma.
News For NVS From The Last 14 Days
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September 4, 2015
05:17 EDTNVSNovartis receives EU approval for Farydak
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September 2, 2015
16:20 EDTNVSHealth Canada approves new indications for PrOmnitrope
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12:22 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Reuters reports
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12:15 EDTNVSAmgen denied injunction to block Novartis copy of Neupogen, Bloomberg reports
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05:35 EDTNVSNovartis receives EU approval for Revolade
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September 1, 2015
16:33 EDTNVSAmgen, Novartis enter agreement for Alzheimer's, migraine research
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August 28, 2015
05:32 EDTNVSNovartis renews pledge with WHO to end leprosy
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August 25, 2015
15:02 EDTNVSMylan says USPTO institutes IPR of two Copaxone patents
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August 24, 2015
13:15 EDTNVSFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:11 EDTNVSNovartis announces FDA approves expanded use for Promacta
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August 21, 2015
05:25 EDTNVSNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.

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