Therapeutics
Emergent BioSolutions IND for Anthrax Monoclonal Antibody Therapeutic Clears FDA Review
Published in Medical Letter on the CDC and FDA, June 6th, 2010
Emergent BioSolutions Inc. (NYSE:EBS) announced that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.
"Emergent is committed to advancing its anthrax franchise, which includes both vaccines and therapeutics that...
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