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Inhibitex Veronate update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Panel of experts will review the firm's Veronate polyclonal immune globulin development program in May, with an assessment due "near the end of June," the firm says. However, "regardless of what we ultimately determine was the cause" of earlier disappointing Phase III results, the firm does not foresee conducting additional clinical trials in very low birth weight infants "with our current donor-selected immune globulin form" of the biologic, Inhibitex states April 28. Earlier in April, Inhibitex reported that Veronate missed all endpoints in a Phase III trial for prevention of hospital-associated infections in premature, very low birth weight infants. Inhibitex "will halt the manufacture of the clinical trial material it has used in the clinical development of Veronate to-date"...

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