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News Breaks
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
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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