FDA refuses to file Advexin:
This article was originally published in Pharmaceutical Approvals Monthly
The first-in-class gene therapy from Introgen gets a "refuse to file" letter from FDA due to an incomplete BLA, the firm announces Sept. 2. Advexin, a tumor suppressor cancer therapy that uses an adenoviral delivery system, was submitted in both the U.S. and Europe in June for treatment of recurrent, refractory head and neck cancer; the European Medicines Agency accepted the filing Aug. 18. Introgen declined to give details on the RTF letter, but said it is meeting with FDA to get more clarity and plans to appeal the action
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