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News Breaks
May 23, 2014
07:47 EDTNVSNovartis provides update on EU marketing authorization application for RLX030
Novartis announced that the Committee for Medicinal Products for Human Use, or CHMP, has adopted a negative opinion for the use of RLX030 in the treatment of acute heart failure, or AHF, indicating that further evidence is required for a license to be granted in the EU. This follows the company's request for re-examination after a previous negative opinion was issued in January. Novartis aims to resubmit for approval as soon as additional data is available from the ongoing global trial program, including the 6,300 patient RELAX-AHF-2 study, one of the largest and most robust programs undertaken by a company for an AHF drug.
News For NVS From The Last 14 Days
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October 1, 2014
16:18 EDTNVSNovartis Bioventures reports 21.3% stake in Tokai Pharmaceuticals
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08:07 EDTNVSEnanta regains full rights to EDP-239 for Hep C virus from Novartis
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September 30, 2014
16:39 EDTNVSCMS discloses drug makers' payments to doctors, WSJ says
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07:30 EDTNVSSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
September 29, 2014
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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September 26, 2014
07:30 EDTNVSNovartis drug Signifor LAR recommended by CHMP for EU approval
The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Signifor long acting release, or LAR, formulation to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. If approved in the EU, this next-generation SSA could fill a current unmet need, providing a new therapeutic option for the approximately 45% of acromegaly patients whose growth hormone, or GH, or insulin-like growth factor-1, or IGF-1, levels remain inadequately controlled despite treatment with currently available SSAs.
September 25, 2014
05:28 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies
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September 22, 2014
16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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