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News Breaks
August 26, 2013
06:01 EDTAMRNAmarin announces submission of sNDA to FDA for Novasep
Amarin announced the submission of a Supplemental New Drug Application to the FDA seeking approval for Novasep Group, S.A.S., through its subsidiary Finorga S.A.S., as an additional Vascepa active pharmaceutical ingredient supplier. Novasep is part of the previously disclosed Slanmhor consortium with which Amarin announced a global supply agreement in 2012. Novasep is building the world's largest chromatography plant using its proprietary chromatography technologies to produce API on behalf of the Slanmhor consortium and Amarin. Amarin anticipates the Novasep facility, located in Mourenx, France, to be qualified and operational for manufacturing in 2014.
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July 31, 2015
07:17 EDTAMRNAmarin announces two presentations on EPA dyslipidemia studies
Amarin announced the presentation of findings from two studies, a retrospective study in which patients were switched from an EPA plus DHA combination product to EPA-only Vascepa as well as a sub-analysis of the ANCHOR clinical trial, at two key cardiovascular meetings. The EPA+DHA to EPA-only switch study investigated the effect of EPA-only omega-3 therapy compared to EPA+DHA therapy on multiple patient lipid parameters. Results of this case series showed a reduction in both triglyceride and low-density lipoprotein cholesterol levels with EPA-only therapy in most of these high-risk statin-treated patients. The ANCHOR sub-analysis is an encore presentation which examined the effect of EPA on high-risk statin-treated patients with persistently high triglyceride levels, showing that icosapent ethyl increased EPA in plasma and red blood cells in a linear, dose-dependent fashion consistent with its triglyceride-lowering effect.
July 24, 2015
16:38 EDTAMRNAmarin files to sell 38.9M series A preference shares in form of ADS for holders
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16:34 EDTAMRNAmarin files to sell 3.89M ordinary shares in form of ADS for holders
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