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

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

More from Archive

More from In Vivo

Podcast: Brain+ CEO Discusses “Groundbreaking” Potential Of CST Assistant For Dementia Patients

 

Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.

Behind The Buyout: Dispatches From The Dealmaking Table

 
• By 

In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By 

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.