FDA gives fast-track status to HIV microbicide

The Food and Drug Administration on Monday granted fast-track review status to a vaginal gel developed by Biosyn to prevent HIV infections, other sexually transmitted diseases, and pregnancy, the Philadelphia Business Journal reports. The product, called C31G, will enter phase III clinical trials early next year. Fast-track status is granted to compounds that the FDA believe will prevent or treat serious illnesses or address unmet medical needs. "We have worked closely with the FDA on the clinical path for this candidate since it is an important production for the prevention of sexual transmission of HIV," said Biosyn president and CEO Anne-Marie Corner.