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February 24, 2014
05:27 EDTNVSFDA granted Bexsero to be used in vaccination program at UCSB
Novartis announced that its meningococcal serogroup B, or MenB, vaccine, Bexsero, will be used as part of a vaccination program at the University of California Santa Barbara, or UCSB, that will end on March 7. In the last three months, the FDA has approved the use of Bexsero twice in response to MenB outbreaks at U.S. college campuses. More than 5,000 students were vaccinated at Princeton University and 20,000 students will be offered vaccination at UCSB. Bexsero is the only licensed broad coverage vaccine approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. It was approved for use in the US under a treatment Investigational New Drug designation. Andrin Oswald, Division Head, Novartis Vaccines said, "We will continue to work with the FDA to pursue a potential license for Bexsero in the U.S. to help fulfill this public health need."
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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
August 7, 2014
08:38 EDTNVSEnanta's HCV NS5A inhibitor EDP-239 advances into combination studies
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