Introgen Submits Advexin Regulatory Applications in the U.S. and Europe
Advexin Targets Gene Defect Common to Majority of Tumors AUSTIN, Texas & DUBLIN, Ireland--(BUSINESS WIRE)--June 30, 2008--Introgen Therapeutics, Inc. submitted...
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Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File
...today announced that the United States Food and Drug Administration (FDA) notified the Company that its Biologics License Application (BLA) for Advexin (p53 tumor suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck, submitted on June 30, 2008,...
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Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008
...and clinical advisors, the Company will include additional patient tissue samples from its Phase 3 trials for p53 biomarker analyses to predict Advexin efficacy to strengthen its U.S. and European regulatory filings. This recommendation was made by the advisors without knowledge of Introgen's Phase...
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