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News Breaks
June 2, 2014
07:41 EDTBMYBristol-Myers announces follow up results from Study -004
Bristol-Myers Squibb Company announced follow up results from Study -004, a multi-arm Phase 1b dose-ranging trial evaluating the safety and activity of the combination regimen of nivolumab, an investigational PD-1 immune checkpoint inhibitor, and Yervoy given either concurrently or sequentially in patients with advanced melanoma. After an additional year of follow up of the cohort that received the concurrent combination regimen of nivolumab 1 mg/kg plus Yervoy 3mg/kg, the one-year overall survival rate was 94% and the two-year OS rate was 88%. These are the doses used in the ongoing Phase 2 and Phase 3 trials, CheckMate -069 and -067. No new safety signals were reported in the concurrent combination cohorts with additional follow up and grade 3-4 treatment-related adverse events occurred in 62% of patients. The most common were asymptomatic increases in lipase, ALT and AST. These data will be presented today at the 50th Annual Meeting of the American Society of Clinical Oncology and featured during an ASCO press briefing at 8 a.m. CDT.
News For BMY From The Last 14 Days
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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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September 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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