BioSante gets drug designation
LINCOLNSHIRE - BioSante Pharmaceuticals Inc. Monday announced BioSante's receipt of Orphan Drug designation from the FDA's Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer. "The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante's first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante's president & CEO. Currently, GVAX Pancreas Vaccine clinical trials are ongoing at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. Patients with pancreatic cancer have one of the poorest 5-year survival rates for any form of cancer.
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