Novartis/Genentech Xolair
Executive Summary
Clinical trials of the allergy and asthma treatment omalizumab are placed on hold after two monkey fatalities in a study of rhuMAb-E-26, a second-generation version of Xolair. The termination was also attributed to thrombocytopenia observed in nonclinical toxicology Xolair studies. One Xolair trial on partial hold will continue but will not enroll new patients. A BLA for Xolair has been pending at FDA since late August
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Genentech Resumes Xolair Phase IIIb Trial After Clinical Hold Is Lifted
Genentech has resumed development of Xolair following the lifting of a clinical hold, VP-Medical Affairs Stephen Dilly, MD, said at the Robertson Stephens Medical Conference in New York Nov. 29. "We addressed the questions that FDA posed...and now the clinical hold has been lifted and we're in a position to implement our Phase IIIb program as planned," he reported.
Genentech Resumes Xolair Phase IIIb Trial After Clinical Hold Is Lifted
Genentech has resumed development of Xolair following the lifting of a clinical hold, VP-Medical Affairs Stephen Dilly, MD, said at the Robertson Stephens Medical Conference in New York Nov. 29. "We addressed the questions that FDA posed...and now the clinical hold has been lifted and we're in a position to implement our Phase IIIb program as planned," he reported.
Xolair Advisory Committee Review Expected By Mid-2001, Tanox Says
Tanox is expecting an FDA advisory committee review for the Novartis/Genentech asthma treatment Xolair (omalizumab) during the first half of 2001.