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
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?