FDA Lifts Clinical Hold On PharmAthene's SparVax Anthrax Vaccine
Thursday, May 30, 2013 - 22:10
in Health & Medicine
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on a proposed Phase II study of SparVax, a next generation recombinant anthrax vaccine, PharmAthene, Inc. announced.The clinical hold was enacted in August 2012, prior to the commencement of a proposed Phase II clinical trial of SparVax. In its notification to the Company, the FDA requested that PharmAthene provide additional stability data for both its engineering and GMP lots of U.S. manufactured Final Drug Product, as well as additional information about the intended stability indicating assays. read more