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

Trius Confident After Phase II Results For Skin Infections, Including MRSA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Trius Therapeutics is headed into Phase III for its lead antibiotic candidate torezolid (TR-701) with an important advantage over other sponsors that have tried for a complicated skin and skin structure claim in the past year: Trius has a clear sense of the outcome FDA now expects to see in a noninferiority study.

You may also be interested in...



Telavancin’s “Complete Response” Letter Calls For Pregnancy-Focused REMS

After a three-day, three-drug advisory committee in November, the last sponsor standing - or at least the last to get a "complete response" letter from FDA - may be in the best position to move forward with its complicated skin and skin structure infections antibiotic

FDA Updating Antibiotic Guidances, But Is It Too Late For Some Sponsors?

It was supposed to be a year with a wealth of novel antibiotics, but regulatory concerns turned 2008 from a year of banner antibiotic approvals into a sizeable crop of action letters. Now the delays are taking a serious toll, causing some sponsors to drastically restructure in the face of uncertain and evolving regulatory standards

Industry’s Lesson On Non-Inferiority Margins In Anti-Infective Trials: Use 10%

If industry is to learn anything from the three-day Anti-Infective Drugs Advisory Committee meeting on how to correctly use non-inferiority margins in trials, it is to adhere to the panel's recommendation of 10 percent (at least for now)

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS004179

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