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News Breaks
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 Japan’s 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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December 16, 2014
08:47 EDTBMYHemispherx Ampligen provides anti-tumor activity
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December 10, 2014
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
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December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
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08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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December 8, 2014
13:32 EDTBMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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December 7, 2014
14:10 EDTBMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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