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...
You may also be interested in...
DOR submits orBec NDA for GVHD
DOR BioPharma announced Sept. 22 its submission of its oral beclomethasone product orBec for treatment of gastrointestinal Graft-versus-Host disease. The Miami-based company reported in November 2005 that the orBec submission was slated for early 2006 (1Pharmaceutical Approvals Monthly December 2005, In Brief). orBec is a two-pill system "designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects," DOR explained. The firm noted that orBec has a fast-track designation and may qualify for a priority review; if granted such a review, the product could reach the market by March 2007. DOR also said it is preparing a European submission for November...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.