Sanofi, KaloBios Pharmaceuticals (KBIO) Granted FDA Fast Track Status for KB001A

April 23, 2013 8:10 AM EDT Send to a Friend
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Sanofi Pasteur, the vaccines division of Sanofi (NYSE: SNY), and KaloBios Pharmaceuticals (Nasdaq: KBIO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically-ventilated patients. The Fast Track Drug Development Program of the FDA is designed to facilitate the clinical development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The joint announcement was made on this second day of the BIO International Convention, the 20th annual meeting of the world's largest biotechnology organization.


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