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 will begin new studies for Restanza

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advanced Life Sciences will conduct a new set of pivotal trials for its antibiotic Restanza, this time with a superiority design. The sponsor announced March 11 that it had met with FDA and reached an agreement for new clinical trials to be conducted under a special protocol assessment (1"The Pink Sheet" DAILY, March 11, 2010). The new pathway will compare Restanza to a marketed macrolide antibiotic, using clinical cure rate in a macrolide-resistant Streptococcus pneumoniae population as the primary endpoint. Restanza's original development occurred in parallel with FDA's refinement of its standards for community-acquired bacterial pneumonia drugs. The agency issued a draft guidance on non-inferiority margins for CABP trials in March 2009, and Advanced Life Sciences' September 2008 application was evaluated based on those standards at a June 2009 advisory committee, where the panel agreed with FDA's conclusion that the efficacy evidence from the non-inferiority trials was insufficient (2"The Pink Sheet," June 8, 2009)

You may also be interested in...



Restanza's New Hope: Advance Life Sciences To Conduct New Pivotal Trials

Company sees options in recommendations from FDA advisory committees for community-acquired bacterial pneumonia and for use of animal efficacy rule for biodefense indications.

Advanced Life Sciences Restanza Blocked By New FDA Efficacy Criteria

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

Why Value-Based Health Care Is Here To Stay

COVID-19 has disrupted the operational schedules of health care and technology providers alike to unparalleled levels in 2020. But scratch the surface, and outcomes-oriented, value-based health care targets remains a priority – albeit competing a little harder for attention at present.

Topics

UsernamePublicRestriction

Register

PS142970

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