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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-naÔve, 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 companyís 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 Japanís Pharmaceutical and Medical Devices Agency.
News For BMY From The Last 14 Days
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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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September 5, 2014
16:45 EDTBMYMarket ends week little changed after mixed economic data
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11:17 EDTBMYBristol-Myers files patent infringement suit against Merck
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September 4, 2014
08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).

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