Janssen's Sirukumab Faces Difficult US Commercial Path Even If It Clears Approval Hurdles
FDA advisory committee's concerns about a mortality imbalance in Plivensia clinical trials would appear to reduce the odds that the interleukin-6 inhibitor will reach the US market in the near term.
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Fourteen medicines that are in the final stages of the evaluation process at the European Medicines Agency should find out this week whether they will be approved for marketing across the EU.
Exclusive contracts for J&J's Remicade have posed challenges for Pfizer's Inflectra in the commercial insurance market, the biosimilar's maker said during its second quarter earnings call.
GSK returned US rights to the IL-6 blocker to J&J as it prioritizes its pharma portfolio under the leadership of new CEO Walmsley.