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10,000 Re-Randomization Sequences Confirm Simponi Efficacy Results

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Centocor demonstrated that an adaptive randomization technique provided comparable results to conventional randomization during pivotal trials for Simponi (golimumab)

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FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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