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News Breaks
January 23, 2013
14:28 EDTNVSNovartis: FDA expands the approved use of Exjade
The U.S. Food and Drug Administration expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion- dependent thalassemia. NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs. The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade. The agency previously cleared FerriScan for measuring liver iron concentration (LIC), but its use in Exjade clinical studies to select patients for therapy, and to manage therapy, defined its role as an imaging companion diagnostic necessary for Exjade's safe and effective use. FerriScan measures LIC non-invasively using magnetic resonance imaging. Exjade is marketed by East Hanover, N.J.-based Novartis (NCS). FerriScan is marketed by Resonance Health, based in Australia.
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August 4, 2015
07:53 EDTNVSEndocyte names Alison Armour chief medical officer
Endocyte (ECYT) announced that Alison A. Armour has been appointed as chief medical officer. Prior to joining Endocyte, Dr. Armour served as vice president of oncology at Novartis (NVS) and GSK (GSK).
July 29, 2015
05:28 EDTNVSNovartis announces equity stake in Mereo BioPharma Group
Novartis announced a swap of clinical assets for equity with Mereo BioPharma Group. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels. Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.
July 24, 2015
10:56 EDTNVSNovartis announces FDA approval of Odomzo
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09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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July 22, 2015
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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