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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.
News For NVS From The Last 14 Days
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March 31, 2015
09:50 EDTNVSMylan launches generic Exforge tablets in U.S.
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March 30, 2015
17:46 EDTNVSNovartis announces FDA approval for Jadenu
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05:18 EDTNVSNovartis enters multiyear aliance with Aduro Biotech
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March 26, 2015
11:13 EDTNVSBofA/Merrill European pharma analyst holds an analyst/industry conference call
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10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
March 24, 2015
11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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March 23, 2015
09:45 EDTNVSUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTNVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says

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