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

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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

You may also be interested in...



FDA Encourages Sponsors Of Hypertension Drugs To Promote Their Cardiovascular Benefits

Final guidance allowing class-wide outcomes claims includes suggested language for both advertising and labeling.

NICE-Style Value-Based Pricing Might Actually Boost Antibiotic Sales In U.S.

Antibiotic development could expand if the U.S. adopted a system to evaluate the drugs’ effectiveness and value to society for reimbursement purposes, similar to that of the British National Institute for Health and Clinical Excellence, according to an article in the Sept. 7 issue of the journal Health Affairs.

NICE-Style Value-Based Pricing Might Actually Boost Antibiotic Sales In U.S.

Antibiotic development could expand if the U.S. adopted a system to evaluate the drugs’ effectiveness and value to society for reimbursement purposes, similar to that of the British National Institute for Health and Clinical Excellence, according to an article in the Sept. 7 issue of the journal Health Affairs.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS004533

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