Please ensure Javascript is enabled for purposes of website accessibility

PharmAthene gets FDA nod on SparVax

PharmAthene gets FDA nod on SparVax

Listen to this article

PharmAthene 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.

Networking Calendar

Submit an entry for the business calendar