Gilead Says FDA Won’t Accept Filing for AIDS Pill
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Gilead Sciences Inc., the world’s largest maker of AIDS drugs, said U.S. regulators didn’t accept an application for a combination AIDS pill pairing Gilead’s Truvada with Johnson & Johnson’s experimental drug TMC278.
The Food and Drug Administration asked for additional information about the chemistry and manufacturing of the proposed once-daily drug, the Foster City, California-based company said today in a statement. Regulators want to know more about an impurity the company found while testing the product, said Norbert Bischofberger, Gilead’s executive vice president for research and development and chief scientific officer.