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Bioniche gets FDA fast-track status for bladder cancer product
By Elaine Rigoli
Tampa, Fla., May 4 - Bioniche Life Sciences, Inc. said the Food and Drug Administration has granted fast-track designation for the company's mycobacterial cell wall-DNA complex (Urocidin) for the treatment of non-muscle invasive bladder cancer in patients who are unresponsive to Bacillus Calmette-Guérin (BCG), the current standard therapy.
BCG is a live, attenuated strain of mycobacterium bovis, a therapy that is often associated with treatment-limiting side effects, according to a news release.
Bioniche, based in Belleville, Ont., is a biopharmaceutical company focused on the discovery, development, manufacturing and marketing of proprietary products for human and animal health markets worldwide.
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