TITLE

BAVARIAN NORDIC GETS FDA FAST TRACK DESIGNATION FOR PROSTVAC

PUB. DATE
June 2010
SOURCE
Worldwide Biotech;Jun2010, Vol. 22 Issue 6, p5
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
51161379

 

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