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News Breaks
November 16, 2012
07:53 EDTNVSNovartis drug Exjade recommended by CHMP for EU approval
Novartis announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Exjade, or deferasirox, for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia, or NTDT, syndromes. Exjade would be the first oral treatment in the European Union, or EU, specifically indicated for the treatment of iron overload in patients with these types of thalassemia. The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 27 EU member states plus Iceland and Norway. Exjade has been approved to treat chronic iron overload in patients with NTDT in Canada and several other countries; further regulatory submissions are ongoing.
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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