New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 19, 2014
16:33 EDTCBSTCubist announces acceptance of Ceftolozane/Tazobactam NDA Priority Review
Cubist Pharmaceuticals announced that the FDA has accepted the company’s New Drug Application, or NDA, for its investigational antibiotic ceftolozane/tazobactam with Priority Review. The FDA has assigned a Prescription Drug User Fee Act action date of December 21. Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. The NDA is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the FDA and the European Medicines Agency specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in patients with complicated infections.
News For CBST From The Last 14 Days
Check below for free stories on CBST the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 18, 2014
05:33 EDTCBSTCubist opens international headquarters in Zurich, will invest $400M in R&D
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