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June 1, 2014
19:15 EDTNVSNovartis announces results of Phase 2 trial of LDE225
Novartis announced the results of a pivotal Phase II trial demonstrating that patients with locally advanced, or metastatic basal cell carcinoma taking the investigational oral compound LDE225, sonidegib, had marked and sustained tumor shrinkage after a median follow-up of 13.9 months.The data were revealed for the first time in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology, ASCO, in Chicago. "These results represent an important milestone in the clinical development of LDE225, as well as in our research strategy to develop new therapies for patients with unmet needs," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "These data will form the basis for the filing of another important new medicine for a skin-related disease in which Novartis is building a leading position." The data from this pivotal trial will serve as the basis for worldwide regulatory filings for the 200 mg dose of LDE225 in advanced basal cell carcinoma.
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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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August 11, 2014
05:18 EDTNVSNovartis reports LCZ696 significantly reduced cardiovascular deaths
New data revealing the reduction in cardiovascular, or CV, deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction, or HF-REF, will be presented at the European Society of Cardiology, or ESC, Congress 2014. The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early. LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF. PARADIGM-HF is the largest heart failure study ever conducted and was stopped early in March due to compelling efficacy. LCZ696 was recently granted FDA Fast Track status and rolling submission expected to be complete by end of year.
August 8, 2014
06:51 EDTNVSJudge rules DOJ can pursue Novartis kickback suit, Reuters says
U.S. District Judge Colleen McMahon ruled that the U.S. Department of Justice is allowed to continue its False Claims Act lawsuit versus Novartis regarding allegations that the company used kickbacks to increase sales of medications covered by Medicare and Medicaid, according to Reuters, citing comments from McMahon. Reference Link

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