Acambis Completes Smallpox Vaccine BLA
This article was originally published in The Pink Sheet Daily
Acambis' ACAM2000 would have a mid-October estimated user fee date if the BLA is granted a priority review
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The firm said it expects to complete the filing by April and receive approval by year-end.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.