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April 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
Bristol-Myers Squibb Company announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir, a NS5A inhibitor, and asunaprevir, a NS3 inhibitor, among genotype 1b hepatitis C virus infected patients. Results showed that the 24-week regimen achieved an overall sustained virologic response 12 weeks after the end of treatment among treatment-naïve, peginterferon/ribavirin non-responder and peginterferon/ribavirin ineligible/intolerant patients, including cirrhotic and non-cirrhotic patients. In the study the DCV+ASV regimen was generally well tolerated. These data will be presented this week at the 49th annual meeting of the European Association for the Study of the Liver The International Liver Congress in London, April 9-13. These data were part of the company’s recent DCV and ASV new drug application submissions to the U.S. Food and Drug Administration, and helped support the validated marketing authorization application to the European Medicines Agency for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. These data are comparable to a similar Phase III study of this regimen in Japanese patients, which led to the submission of a New Drug Application with Japan’s Pharmaceutical and Medical Devices Agency.
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September 29, 2014
08:22 EDTBMYBristol-Myers says EMA validates MAA for Nivolumab in NSCLC
Bristol-Myers Squibb announced that the European Medicines Agency has validated for review the Marketing Authorization Application for nivolumab in non-small cell lung cancer– the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. The MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC. In addition to the MAA for lung cancer in the E.U., the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.
07:26 EDTBMYInforma Business Information to hold a conference
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05:32 EDTBMYBristol-Myers announces positive Phase 3 data for Opdivo
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September 26, 2014
16:20 EDTBMYBristol-Myers announces multiple regulatory milestones for Opdivo in U.S., EU
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September 23, 2014
12:10 EDTBMYBristol-Myers to build 650,000 square foot campus in Lawrenceville, NJ
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September 22, 2014
07:21 EDTBMYEBD Group to hold a conference
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September 17, 2014
07:43 EDTBMYBofA/Merrill to hold a conference
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September 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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