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News Breaks
June 24, 2014
08:01 EDTBMYBristol-Myers expands access to clinical trial data through DCRI collaboration
Bristol-Myers Squibb announced a collaboration with Duke University through its Duke Clinical Research Institute focused on clinical trial transparency. Bristol-Myers Squibb will expand access to a broader set of clinical trial information from in-scope company-sponsored studies and enable an independent scientific review through DCRI of requests from researchers that meet pre-specified requirements. The collaboration with DCRI is one of a series of initiatives by Bristol-Myers Squibb to support data sharing and enhance the company’s existing policies on transparency and disclosure of clinical trial information. Clinical trial information being made available for scientific research will include protocols, full clinical study reports and de-identified patient-level data and study-level data for medicines and indications approved in the U.S. and/or Europe for trials completed after January 2008. Information from terminated programs will be available two years after discontinuation. Bristol-Myers Squibb will also publish CSR synopses for studies that support a product’s marketing authorization application to the U.S. Food and Drug Administration or the European Medicines Agency shortly after the regulatory approval of the product has been granted. The company has also committed to provide lay-language summaries of clinical trial results for patients who participated in clinical trials and wish to receive a summary of the aggregate study level results. Bristol-Myers Squibb is working with various industry groups and regulators to evaluate the most effective method to deliver this level of detail to patients.
News For BMY From The Last 14 Days
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May 22, 2015
10:52 EDTBMYJPMorgan says Actavis shares cheap compared to peers
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07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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May 21, 2015
07:37 EDTBMYPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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07:21 EDTBMYUBS to hold a conference
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May 19, 2015
08:57 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMYGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
May 14, 2015
11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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May 13, 2015
13:12 EDTBMYSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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