GSK, Bayer await FDA rulings on blood drug candidates

05/21/2009 | Reuters

U.S. drug regulators are expected to hand down their decisions on GlaxoSmithKline's leukemia drug Arzerra and Bayer's blood thinner Xarelto late next week. Analysts predicted that the agency will ask for a risk-evaluation plan for Xarelto, which is co-developed by Johnson & Johnson, because of concerns about long-term use, possibly delaying its approval for three to six months. Arzerra, which is co-developed by Genmab, is widely expected to get an FDA panel's endorsement.

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