Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Cubist To Seek Cubicin sNDA Priority Review For Endocarditis, Bacteremia

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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

You may also be interested in...



Cubicin Endocarditis Trial Shows Improved Renal Safety Over Vancomycin

Pivotal data for Cubist's Cubicin treatment of endocarditis/bacteremia show comparable efficacy to standard care with superior renal safety, the firm reported Dec. 16

Cubist Cubicin S. aureus sNDA

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...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

UsernamePublicRestriction

Register

LL1135972

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel