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 1, 2014
11:26 EDTCBSTAmerican Society for Microbiology to hold a conference
Subscribe for More Information
August 31, 2014
14:04 EDTCBSTWorldwide Business Research to hold a conference
Subscribe for More Information
August 22, 2014
07:31 EDTCBSTCubist annouces EMA acceptance of ceftolozane, tazobactam MAA
Cubist announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane, tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission expected during 1H15. The MAA submission 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 EMA and U.S. Food and Drug Administration specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes.

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