US FDA Panel Weighs Design Of A Pre-approval Safety Study For Janssen's Sirukumab
IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.
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The latest drug development news and highlights from our FDA Performance Tracker.
As positive efficacy data rolls in for the janus kinase inhibitors in rheumatoid arthritis, like Pfizer’s Phase III tasocitinib, elevated lipid levels are emerging as an issue worth keeping an eye on.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’