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news.Antigenics, a biotechnology company, has announced that the FDA has granted the necessary permission to allow for the export of Oncophage to Russia.
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The FDA export license clears the way to provide patients in Russia with Oncophage, which will continue to be manufactured at the company’s facility in Lexington, Massachusetts.
The Russian Ministry of Public Health approved the therapeutic cancer vaccine in April 2008 for the adjuvant treatment of kidney cancer patients at intermediate risk for disease recurrence.
Antigenics remains on target to submit a marketing authorization application to the European Medicines Agency before the end of 2008 as well as continuing to explore other major geographical territories for regulatory approval of Oncophage.