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Wednesday, Aug 1
2012, 7:24 PM
Baxter (BAX) confirms it's received a complete response letter from the FDA delaying the...
Baxter (BAX) confirms it's received a complete response letter from the FDA delaying the approval of its investigational product HyQ. More specifically, the agency says it's seeking additional preclinical data focusing on issues related to non-neutralizing antibodies and the possible effects they have on reproduction, development and fertility. HyQ, which is in development with Halozyme Therapeutics (HALO), is a treatment that aims to allow physicians to tailor antibody drug therapy to the needs of patients with immune-system disorders. BAX -0.6%, HALO -54% AH.