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News Breaks
April 7, 2014
08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
Bristol-Myers Squibb Company has submitted new drug applications with the U.S. Food and Drug Administration for the investigational products daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C. The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing. These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.
News For BMY From The Last 14 Days
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January 29, 2015
17:23 EDTBMYBristol-Myers gets FDA approval for Evotaz to treat HIV-1 infections
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08:14 EDTBMYCelldex, Bristol-Myers initiate Phase 1/2 Varlilumab, Opdivo combination study
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January 27, 2015
07:37 EDTBMYBristol-Myers sees FY15 EPS $1.55-$1.70, consensus $1.71
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07:31 EDTBMYBristol-Myers reports Q4 EPS 46c, consensus 41c
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January 26, 2015
15:40 EDTBMYNotable companies reporting before tomorrow's open
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11:29 EDTBMYBristol-Myers January weekly volatility increases into Q4 and outlook
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January 22, 2015
08:49 EDTBMYBristol-Myers price target raised to $70 from $63 at SunTrust
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January 21, 2015
10:16 EDTBMYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
16:34 EDTBMYBristol-Myers appoints Giovanni Caforio CEO
Bristol-Myers Squibb announced a number of leadership changes approved by its board of directors and effective at the close of the annual Shareholders’ Meeting on May. Giovanni Caforio, M.D. will become CEO of the company. Lamberto Andreotti will become executive chairman of the board of directors on May 5 and will continue to serve as chairman after his retirement on August 3. James M. Cornelius, 71, has chosen not to stand for re-election as non-executive chairman and will retire from the board. Togo D. West, Jr., 72, will become the lead independent director on the company’s board.

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