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June 2, 2014
09:07 EDTNVSNovartis presents LBH589 data at ASCO
Novartis data at ASCO show LBH589 significantly improved progression-free survival in patients with multiple myeloma. Processed and transmitted by NASDAQ OMX Corporate Solutions. Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint. Median PFS increased by 4 months, effect of LBH589 observed across all patient subgroups. Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents available to this population. Based on these data, US FDA granted priority review in May; additional global regulatory filings are underway. The company said, "Almost all patients with multiple myeloma ultimately relapse and become resistant to treatment, so new therapies are critical for continuing to manage the disease and improve outcomes. These are the first Phase III results to show meaningful clinical benefit and provide scientific support for adding LBH589 to bortezomib-based treatment for patients with relapsed or relapsed and refractory multiple myeloma and provide a strong rationale for the use of histone deacetylase inhibitors as part of the therapeutic armamentarium in this setting."
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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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