June 2010
Worldwide Biotech;Jun2010, Vol. 22 Issue 6, p5
Trade Publication
The article reports on the Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to Bavarian Nordic A/S of Denmark for its PROSTVAC in June 2010, which is designed to treat men with metastatic castration-resistant prostate cancer (mCRPC). It says that PROSTVAC showed a possible survival benefit and a great safety profile. According to the author, the company can also submit a biologics license application (BLA) as part of the program. The terms of the Fast Track program and the prevalence of prostate cancer are also discussed.


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