New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

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
Sign up for a free trial to see the rest of the stories you've been missing.
December 16, 2014
08:47 EDTBMYHemispherx Ampligen provides anti-tumor activity
Subscribe for More Information
December 10, 2014
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
Subscribe for More Information
December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
Subscribe for More Information
08:25 EDTBMYBristol-Myers data positive, says BMO Capital
Subscribe for More Information
December 8, 2014
13:32 EDTBMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use