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

Advanced Life Sciences Restanza Blocked By New FDA Efficacy Criteria

Executive Summary

Advanced Life Sciences has not given up on developing its investigational drug Restanza (cethromycin) for community acquired pneumonia, despite a June 2 recommendation by the FDA Anti-infective Drugs Advisory Committee that the drug should not be approved for CAP due to lack of efficacy

You may also be interested in...



Non-Inferiority Studies May (Bio)Creep Out Of Limelight After GAO Report

A report on FDA's use of non-inferiority trials by the Government Accountability Office could in fact signal the end of the political wrangling over the study method

Non-Inferiority Studies May (Bio)Creep Out Of Limelight After GAO Report

A report on FDA's use of non-inferiority trials by the Government Accountability Office could in fact signal the end of the political wrangling over the study method

Restanza Superiority Trials Intended To Avoid Non-Inferiority "Quagmire"

Advanced Life Sciences CEO Michael Flavin decided a pair of superiority trials was the best way to prove the efficacy of the company’s Restanza in community-acquired bacterial pneumonia, given the "stalemate" at FDA regarding the use of non-inferiority trials in antibiotics.

Related Content

Topics

UsernamePublicRestriction

Register

MT125529

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