Cubist Cubicin S. aureus sNDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cubist is requesting a priority review for its Cubicin (daptomycin) sNDA filing for treatment of endocarditis and bacteremia caused by Staphylococcus aureus, the firm says Sept. 26. Cubist previously expressed confidence that its pivotal trial supports a broad label. Cubicin showed higher success rates than comparator therapy in the Phase III trial, although those rates did not reach statistical significance (1Pharmaceutical Approvals Monthly July 2005, p. 5). The data will be presented for the first time at the Interscience Conference on Antimicrobial Agents and Chemotherapy Dec. 16-19 in Washington, D.C...
You may also be interested in...
Cubist To Seek Cubicin sNDA Priority Review For Endocarditis, Bacteremia
Cubist plans to request a priority review for an sNDA it will submit by year-end for use of its Cubicin antibiotic for endocarditis and bacteremia
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.