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News Breaks
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 1, 2014
08:14 EDTBMYPortola announces Phase 3 ANNEXA study met primary, secondary endpoints
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07:52 EDTBMYJ&J purchase of Alios an incremental negative for Achillion, says UBS
UBS views Johnson & Johnson's (JNJ) purchase of Alios as an incremental negative for Achillion (ACHN), as it implies there is now one less potential buyer of the company. However, the firm still thinks ACH-3422 will have considerable strategic value after data is reported and that other HCV players such as AbbVie (ABBV) and Bristol-Myers (BMY) are likely to be interested. UBS maintains its Buy rating and $15 price target on Achillion.
September 30, 2014
17:02 EDTBMYBristol-Myers to transfer $1.4B in U.S. pension obligations to Prudential
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16:39 EDTBMYCMS discloses drug makers' payments to doctors, WSJ says
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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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