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November 12, 2012
15:33 EDTBMYBristol-Myers reports data for studies of Hep C compounds
Bristol-Myers Squibb announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a with the investigational direct-acting antiviral daclatasvir and ribavirin, achieved sustained virologic response 12 weeks post-treatment in 93%, or 13/14, of treatment-naïve, genotype 1b chronic hepatitis C patients who achieved a protocol-defined response. The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76%, or 28/37. These study findings were presented in a late breaker presentation at the American Association for the Study of Liver Diseases congress in Boston. The company also presented SVR4 results from the D-LITE Japanese sub-study, where all subjects were infected with HCV genotype 1b and SVR12 was 100%. SVR results from the EMERGE Phase IIb study of Lambda versus alfa interferon in treatment-naïve genotype 1 or 4 patients were also presented. In the D-LITE study, adverse events were mostly low grade and self-limiting. In the Lambda/RBV/DCV treatment group, only one of 37 patients experienced a serious adverse event, breast cancer, which was unrelated to study drug. The lead investigator said, “Treatment with lambda interferon combined with daclatasvir and ribavirin achieved high rates of sustained virologic response, and the data support further study of regimens using lambda interferon to address the medical needs of hepatitis C patients who cannot use alfa interferons.”
News For BMY From The Last 14 Days
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October 21, 2014
07:15 EDTBMYFDA to hold workshop on breast cancer drug development
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October 20, 2014
07:19 EDTBMYIBC Life Sciences to hold a conference
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October 16, 2014
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
09:57 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
11:23 EDTBMYBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:13 EDTBMYBioFlorida to hold a conference
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October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:19 EDTBMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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October 8, 2014
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:18 EDTBMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.

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