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News Breaks
March 6, 2014
05:30 EDTNVSNovartis announces Xolair approved in EU
Novartis announced that the European Commission has approved the use of Xolair, omalizumab, as an add-on therapy for the treatment of chronic spontaneous urticarial, or CSU, in adult and adolescent patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks. The EU approval follows the Committee for Medicinal Products for Human Use positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase III registration studies that involved nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre- specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. Quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study program.
News For NVS From The Last 14 Days
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October 1, 2014
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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