Case Study #2: Why Waiting Is Better For Advanced Life Sciences
This article was originally published in Pharmaceutical Approvals Monthly
While companies like Replidyne and Sanofi-Aventis have been caught in the evolving regulatory standards for non-inferiority trial design in antibiotics, one firm has elected to wait for further clarification before submitting a new drug application.
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Louisville, Colo.-based Replidyne is particularly invested in the recent FDA draft guidances concerning the use of non-inferiority trial designs in anti-infective studies: the NDA submission for their lead candidate, faropenem medoxomil, is caught in the midst of evolving standards for anti-infective approvals.
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class