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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Non-Inferiority Trials, Please, US FDA Implores Rheumatoid Arthritis Sponsors
RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.
Keeping Track: An RMAT, Two QIDPs, And Some Bad News Too
The latest drug development news and highlights from our FDA Performance Tracker.
JAK Inhibitors Could Face Scrutiny Over Cholesterol Effects
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.