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June 3, 2014
10:51 EDTNVS, INCYNovartis, Incyte announce results from RESPONSE trial evaluating ruxolitinib
Novartis (NVS) and Incyte (INCY) announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera. Jakavi, or ruxolitinib, improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea[. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology. Ruxolitinib was well tolerated and adverse events were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis. Within the first 32 weeks of treatment, Grade 3 or 4 hematologic AEs in the ruxolitinib treatment arm were anemia and thrombocytopenia and fewer patients treated with ruxolitinib experienced thromboembolic events when compared to those who received best available therapy. The most common non-hematologic AEs were headache, diarrhea and fatigue. Additionally, 3.6% of patients randomized to the ruxolitinib treatment arm discontinued treatment due to AEs compared to 1.8% on the best available therapy arm. Data from the RESPONSE trial will support worldwide regulatory submissions planned this year.
News For NVS;INCY From The Last 14 Days
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August 31, 2014
14:04 EDTNVSWorldwide Business Research to hold a conference
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13:47 EDTNVSNovartis heart failure drug LCZ696 shows superiority to enalapril in study
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12:50 EDTNVSEuropean Society of Cardiology to hold a conference
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August 29, 2014
16:21 EDTNVSOn The Fly: Closing Wrap
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12:23 EDTNVSNovartis drug data to be presented this weekend
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12:18 EDTNVSOn The Fly: Midday Wrap
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11:07 EDTNVSHigh option volume stocks
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10:51 EDTNVSUnited Therapeutics jumps after court rules generic will infringe
United Therapeutics (UTHR) alleged patent infringement against Sandoz, a unit of Novartis (NVS), related to the latter's filing for approval of a generic version of United Therapeutics' remodulin drug. A New Jersey court ruled today that Sandoz's proposed ANDA product will infringe the claims of UTC's '117 patent, according to a court filing. Following the court ruling, shares of United Therapeutics are up 15% to $105.39 in morning trading.
10:17 EDTNVSInnoPharma announces FDA approval of generic Dacogen
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10:04 EDTNVSNovartis hematopoietic support for ALL patients granted orphan status
Novartis' hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor antagonist was granted orphan designation as a hematopoietic support in patients with acute lymphoblastic leukemia, or ALL, the FDA stated. Reference Link
08:46 EDTNVSNovartis has a conference call hosted by JPMorgan
JPMorgan Analyst Vosser hosts a conference call with CEO Joe Jimenez on September 5 at 8 am.
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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