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AstraZeneca's Motavizumab May Be The Canary In The Follow-On Coal Mine

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC’s motavizumab, which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. This suggests the government agency’s standards may be changing on a range of issues, from comparative effectiveness to data integrity.

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC's motavizumab ( Rezield), which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. On June 2, the application suffered a 14-3 "no" vote from FDA's Antiviral Drugs Advisory Committee, suggesting the government agency's standards may be changing on a range of issues, from comparative effectiveness to data integrity.

Motavizumab is being positioned as the successor to Synagis (palivizumab ), the $1.1 billion antibody from AstraZeneca's biologics unit

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