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PharmAthene gets FDA nod on SparVax
PharmAthene gets FDA nod on SparVax
Listen to this articlePharmAthene Inc., of Annapolis, a biodefense company developing medical countermeasures against biological and chemical threats, announced that the U.S. Food and Drug Administration has lifted a nearly-10-month hold placed on a proposed Phase II study of SparVax, allowing a clinical trial of the next-generation anthrax vaccine to proceed.
The clinical hold was placed in August 2012, prior to the start of a proposed Phase II clinical trial of SparVax.
The FDA requested the company provide additional stability data for batches of U.S.-manufactured Final Drug Product, as well as additional information about the intended stability-indicating assays.
In a later letter to the company, the FDA said the clinical-hold issues had been satisfactorily addressed.
