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

HGS Refines LymphoStat-B Lupus Trial Design After Phase II Misses Endpoints

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Human Genome Sciences believes it can move ahead with Phase III trials of its systemic lupus erythematosus therapy LymphoStat-B but will refine the clinical study design - including clinical endpoints - from that used in Phase II

You may also be interested in...



HGS/GSK On Track To Initiate Lymphostat-B Phase III Study In 2006

Human Genome Sciences and its development partner GlaxoSmithKline are on track to initiate a Phase III study of LymphoStat-B for the treatment of systemic lupus erythematosus in 2006, HGS said.

Genelabs Prestara update

Genelabs plans to meet with FDA "to discuss the company's options with regard to the development of Prestara [prasterone] for lupus," the firm says June 22. Future development of Prestara also hinges on the outcome of an open-label extension study of a failed confirmatory trial looking at the agent's effect on bone mineral density. The trial is slated to complete in August 2005. "While [the study] may provide useful data on the effect of Prestara on bone mineral density of women with lupus over a longer period of time, the FDA normally does not consider such open-label studies to be sufficient to support approval of a new drug," Genelabs noted. La Jolla is currently conducting a confirmatory trial for its lupus agent Riquent (abetimus) (1Pharmaceutical Approvals Monthly November 2004, p. 13); Immunomedics' monoclonal antibody epratuzumab recently entered Phase III for the autoimmune disease...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003074

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