AstraZeneca's Rezield Hits Another Regulatory Wall
This article was originally published in Pharmaceutical Approvals Monthly
FDA's request for another clinical trial before approving MedImmune's Rezield for prevention of respiratory syncytial virus could reflect an advisory committee's recommendations that the company show some advantage over its currently approved RSV agent, Synagis, particularly in sicker children
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Agency may have needed more time to investigate allegations in a wrongful discharge lawsuit challenging data integrity in a motavizumab surveillance study.
Alongside FDA's concerns about possible bias in the Phase III clinical trials of Rezield (motavizumab), MedImmune faces an accusation of data suppression from a former employee who alleges he was fired for bringing up problems with sample screening
AstraZeneca subsidiary MedImmune received a "complete response" letter from FDA for its RSV drug motavizumab that did not request additional clinical data, but after an unfavorable advisory committee a year and a half later, the company is looking at the prospect of having to do another trial anyway