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Stock Market & Financial Investment News

News Breaks
March 25, 2014
11:26 EDTNVSDoctor recommends FDA not approve Novartis heart drug
In a clinical review made available as part of briefing documents ahead of an FDA advisory panel meeting, doctors Melanie Blank and Tzu-Yun McDowell recommended that Novartis' serelaxin not be approved at this time "because there is insufficient evidence to support the proposed indication," which is to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. The advising doctors added that they did not identify any significant safety concerns precluding approval. The briefing documents were posted on the FDA website ahead of a cardiovascular and renal drugs advisory committee meeting scheduled for March 27. Reference Link
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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