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

Lilly Xigris Label Could Exclude Lower-Risk And Sickest Sepsis Patients

Executive Summary

Xigris, if approved, should be restricted to those severe sepsis patients defined by exclusion criteria in Lilly's pivotal trial, FDA's Anti-Infective Drug Advisory Committee recommended Oct. 16.

You may also be interested in...



Generic Biologics On FDA Fast Track?: “Follow-On” Process Under Debate

Data requirements for generic biologics approved under the 505(b)(2) process will be taken up by FDA over the next six months, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said

Generic Biologics On FDA Fast Track?: “Follow-On” Process Under Debate

Data requirements for generic biologics approved under the 505(b)(2) process will be taken up by FDA over the next six months, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said

Lilly Xigris Sepsis Benefit Defended By FDA In NEJM 

An FDA analysis of Xigris PROWESS trial data suggests that Lilly's tightening of patient exclusion criteria during the study does not account for greater drug benefit seen after the protocol change

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS038701

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