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


FDA's New Skin Infection Endpoint Needs Refinement, Advisory Panel Says

Executive Summary

The new endpoint proposed in FDA’s recent acute bacterial skin and skin structure infections guidance – cessation of lesion spread – needs further refinement to be a reliable assessment of antibiotic efficacy, according to members of the agency’s Anti-Infective Drugs Advisory Committee.

You may also be interested in...

Tedizolid, Dalbavancin Still Face Questions On ABSSSI Lesion Measurement

Both antibiotics gain a strong positive recommendation from FDA advisory committee, but questions about how skin lesions were measured before and during treatment persist as experience with new endpoint increases.

Trius Antibiotic Tedizolid Hits Old, New And In-Between Endpoints

Tedizolid, a next-generation antibiotic from the same class as Pfizer’s Zyvox, has met all complicated skin infection endpoints for both a U.S. and European filing, and Trius plans submissions in second half 2013 and first half 2014, respectively. European partnering talks, meanwhile, have gained new intensity.

PhRMA Urges FDA To Set Non-Inferiority Margin For Skin Infection Drugs

FDA should provide more specificity on the non-inferiority margin it expects clinical trials for acute bacterial skin and skin structure infection (ABSSSI) treatments to satisfy, pharmaceutical companies and infectious disease specialists say.

Related Content


Latest News
See All



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