The US FDA could require Janssen Biotech Inc. to conduct a preapproval, comparative safety study of its interleukin-6 inhibitor Plivensia (sirukumab) due to a mortality imbalance in the pivotal trials, but agency staff said they are not contemplating an across-the-board study requirement for similar products.
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 US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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