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July 7, 2014
07:01 EDTBMYBristol-Myers says Daklinza approved by Japan's MHLW
Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare has approved Daklinza, a potent, pan-genotypic NS5A replication complex inhibitor, and Sunvepra, a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japanís first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus infection, including those with compensated cirrhosis. The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy. The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 rates of 90.9%.
News For BMY From The Last 14 Days
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August 21, 2014
13:32 EDTBMYBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
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August 20, 2014
08:03 EDTBMYBristol-Myers Pfizer to present new Eliquis data
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08:02 EDTBMYBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 18, 2014
07:57 EDTBMYCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 8, 2014
10:03 EDTBMYBristol-Myers Hodgkin lymphoma treatment granted orphan drug status
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August 7, 2014
11:02 EDTBMYBristol-Myers enters development pact with Leica Biosystem
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