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DOR BioPharma orBec plans

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

DOR BioPharma plans to submit an NDA in "early 2006" for orBec (oral beclomethasone dipropionate) for treatment of intestinal Graft-versus-Host disease, the firm says Nov. 15. The Miami-based company said the announcement follows a Nov. 1 meeting with FDA's oncology division. The plans to move ahead with an NDA come despite orBec's failure to meet its primary endpoint of time to treatment failure in a 129-patient pivotal trial; results were announced in December 2004. DOR originally intended to submit the orBec NDA by the fourth quarter of 2005. DOR's other projects include vaccines against botulinum and ricin toxins...
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