Medarex, PhamAthene receive fast track designation to develop anthrax cure
Two companies allowed to move at an accelerated pace to develop Anthrax medication
The Food and Drug Administration (FDA) has granted two companies — Princeton, New Jersey-based Medarex (Nasdaq: MEDX) and Annapolis, Maryland-based PharmAthene, a privately held biotechnology company specializing in developing biodefense products — Fast Track designation for Valortim (MDX-1303) against anthrax infection. Valortim is an investigational fully human antibody created using Medarex’s UltiMAb Human Antibody Development System which targets the Bacillus anthracis protective antigen.
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs, and that the FDA will facilitate the development and expedite the regulatory review of the product.
-read more in Medarex news release
