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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 companyís 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 productís 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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November 24, 2015
07:01 EDTBMYBristol-Myers announces EC approved reconciliation of indications for nivolumab
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06:58 EDTBMYBristol-Myers announces FDA approval of Opdivo injection
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November 23, 2015
19:29 EDTBMYBristol-Myers receives FDA approval for Opdivo
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15:00 EDTBMYFDA approves Bristol-Myers drug to treat form of kidney cancer
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November 18, 2015
12:01 EDTBMYBristol-Myers Squibb says Opdivo data shows 'superior' overall survival
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08:11 EDTBMYIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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November 17, 2015
10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.

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