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News Breaks
June 17, 2014
05:33 EDTNVSNovartis submits BLA to FDA for Bexsero
Novartis announced the submission of a Biologic License Application, or BLA, to the FDA for marketing approval for the use of Bexsero to help protect against invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April.
News For NVS From The Last 14 Days
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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
August 7, 2014
08:38 EDTNVSEnanta's HCV NS5A inhibitor EDP-239 advances into combination studies
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