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

FDA Panel Votes For Theravance’s Telavancin, Against Targanta’s Oritavancin

This article was originally published in The Pink Sheet Daily

Executive Summary

Telavancin’s safety concerns did not stand in its way, but oritavancin’s efficacy concerns in treating MRSA did.

You may also be interested in...



Targanta’s Oritavancin Gets FDA “Complete Response”; Additional Phase III Needed

Agency requests Phase III study with MRSA subgroup: cost of additional study could lead company to seek development partner.

Targanta’s Oritavancin Gets FDA “Complete Response”; Additional Phase III Needed

Agency requests Phase III study with MRSA subgroup: cost of additional study could lead company to seek development partner.

J&J/Basilea's Ceftobiprole Faces Another Setback

A Nov. 26 FDA complete response letter to Johnson & Johnson and Basilea Pharmaceutica for their antibiotic ceftobiprole cites deficiencies of study conduct and requests further clinical site audits

Related Content

Topics

UsernamePublicRestriction

Register

PS067037

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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