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June 27, 2014
07:01 EDTBMYBristol-Myers receives positive CHMP opinion for Daklinza for treatment of HCV
Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japanís Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act of November 30.
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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