Drug Development

U.S. FDA grants orphan drug status to monoclonal antibody for treating type 1 diabetes

Published in Blood Weekly, March 16th, 2006

TolerRx, Inc. announced that its lead product, TRX4, has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of new-onset type 1 diabetes mellitus. TolerRx is currently conducting a clinical study of TRX4 in the U.S. in subjects with type 1 diabetes.

Orphan drug designation would entitle TolerRx to exclusive TRX4 marketing rights in the United States for 7 years should TolerRx be the first company to receive marketing approval for this type of therapeutic drug product. In addition, the designation would allow TolerRx to apply for research funding, tax credits for certain research expenses, and a waiver from the FDA...

Want to see the full article?

Purchase this article for only $3.00

We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.

Welcome to NewsRx!

Learn more about a six-week, no-risk free trial of Blood Weekly

Source: Blood Weekly (2006-03-16)

NewsRx is Social

Top Medical Newsletters

Awards

Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005

Facts & Stats

NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

Google 2010 PageRank: #2 Among Top Health News and Media Publications
Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry