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News Breaks
June 10, 2014
18:43 EDTBMYBristol-Myers: AVERT trial shows high rates of DAS-defined remission
Bristol-Myers Squibb announced its first release of new data from a Phase IIIb RA trial showing that the T-cell co-stimulation modulator, Orencia, in combination with methotrexate achieved significantly higher rates of DAS-defined (DAS28 CRP <2.6) remission at 12 months than treatment with standard of care agent MTX - 60.9% vs. 45.2%, respectively, in biologic and MTX-naïve patients with early active RA. The data are being presented this week at the 2014 annual meeting of the European League Against Rheumatism. In this trial, known as AVERT, a co-primary endpoint assessed maintenance of remission following the withdrawal of all RA drug therapy including Orencia, MTX and steroids. A small but statistically significantly higher number of patients treated with Orencia plus MTX, versus MTX alone, for 12 months maintained remission 6 months after all RA treatment was withdrawn. Orencia was well tolerated in the study patients. In particular, serious adverse events, serious infection events and discontinuation due to serious adverse events were comparable to patients treated with MTX. “These data demonstrating higher remission rates and a similar safety profile for Orencia plus methotrexate versus methotrexate alone, in conjunction with insights from the withdrawal phase of the study, support the use of Orencia as a first line biologic therapy for patients with RA,” said Michael Giordano, senior vice president, head of development, Oncology and Immunology, Bristol-Myers Squibb.
News For BMY From The Last 14 Days
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October 24, 2014
16:02 EDTBMYOptions Update; October 24, 2014
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11:15 EDTBMYBristol-Myers says has capacity for large deal
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10:42 EDTBMYBristol-Myers sees coming in closer to high end of FY14 EPS guidance
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10:10 EDTBMYBristol-Myers to host conference call
Conference call to review data presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology (CMSTO) will be held on October 31 at 2:30 pm. Webcast Link
07:35 EDTBMYBristol-Myers reports Q3 Eliquis revenue $216M
Reports Q3 Baraclude revenue $325M, Sprycel revenue $385M, Yervoy revenue $350M. Reports Q3 Abilify revenue $449M, Orencia revenue $444M.
07:33 EDTBMYBristol-Myers confirms FY14 adjusted EPS view $1.70-$1.80, consensus $1.78
Cuts FY14 GAAP EPS view to $1.15-$1.25 from $1.50-$1.60. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2014. Sees FY14 worldwide revenue $15.2B-$15.8B, consensus $15.58B. Also sees: Full-year gross margin as a percentage of revenues between 75% and 76%. Advertising and promotion expense decreasing in the mid-teen-digit range. Marketing, sales and administrative expenses decreasing in the mid-single-digit range. Research and development expenses growing in the mid-single-digit range. An effective tax rate of 19% - 20%.
07:31 EDTBMYBristol-Myers reports Q3 adjusted EPS 45c, consensus 42c
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October 23, 2014
15:39 EDTBMYNotable companies reporting before tomorrow's open
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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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