Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051129

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