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January 24, 2013
15:19 EDTNVSNovartis says subpoenaed during 2012 over marketing practices
In its 2012 annual report, filed yesterday, Novartis Pharmaceuticals disclosed that during last year it received a subpoena from the United States Attorney’s Office for the Western District of Kentucky requesting the production of documents relating to marketing practices, including remuneration of healthcare providers, in connection with certain NPC products including Tekturna and its combination products. Novartis said it is cooperating with the investigation, which is civil and criminal in nature. Novartis also disclosed that in 2012 it received a civil investigative demand from the USAO for the Southern District of New York requesting information regarding its interactions with specialty pharmacies concerning certain NPC products including Gleevec and Gilenya. NPC again said it is cooperating with the civil investigation. Novartis also said that during the fourth quarter of 2012, it learned that the U.S. government is not pursuing further informed consent issues relating to clinical trials in China related to an investigation that began in 2010. The government continues to investigate marketing practices, including marketing practices concerning Zometa, Novartis said. Additionally, Novartis' Alcon Laboratories unit was notified that the USAO for the Northern District of Texas is conducting an investigation relating to the export of Alcon products to various countries subject to U.S. trade sanctions, including Iran, and received a grand jury subpoena requesting the production of documents for a period beginning in 2005 relating to this investigation, in which Alcon is cooperating.
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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.

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