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April 29, 2014
05:53 EDTNVSCHMP recommends EU label expansion of Novartis' Gilenya
Novartis announced that the Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion to expand the EU label for Gilenya in relapsing remitting multiple sclerosis, or RRMS. The recommendation is to expand the label to include adult patients who have not responded to at least one disease-modifying therapy, or DMT, including newly-approved oral DMTs. Gilenya is currently licensed in the EU for adult patients with RRMS who have not responded to treatment with interferons, or have rapidly evolving severe MS. Novartis also announced new pooled analyses from the pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis, confirming the consistent efficacy of Gilenya across four key measures of MS. Addressing these four measures through effective treatment and disease management is important for improving the course of MS for patients.
News For NVS From The Last 14 Days
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August 28, 2014
08:40 EDTNVSPositive data on Novartis LCZ696 could raise sales outlook, says Leerink
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August 20, 2014
12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
05:11 EDTNVSGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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