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AstraZeneca's Rezield Might Itself Be Saved By Sicker Patients

This article was originally published in The Pink Sheet Daily

Executive Summary

Members of FDA's Antiviral Drugs Advisory Committee say that MedImmune's RSV drug Rezield (motavizumab) doesn't pass the risk-benefit test for healthier patients, but it might for sicker patients.

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Company takes a $445 million charge after apparently opting not to undertake an additional trial that FDA had requested following an advisory committee, but the firm is still pursuing a possible claim for treatment of respiratory syncytial virus disease.

AstraZeneca Pulls Motavizumab Prophylaxis BLA, But Phase II Trial Continues

Company takes a $445 million charge after apparently opting not to undertake an additional trial that FDA had requested following an advisory committee, but the firm is still pursuing a possible claim for treatment of respiratory syncytial virus disease.

AstraZeneca's Rezield Hits Another Regulatory Wall

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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