Novartis, D&A Pharma Prepare For High-Stake EMA Meetings

 
• By Neena Brizmohun
  
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Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.

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The EMA is holding several high-stake oral explanation meetings this week • Source: Shutterstock

Novartis is among the sponsors that are this week expected to attend an oral explanation meeting with the European Medicines Agency about their applications for pan-EU marketing approval that have reached the latter stages of the regulatory review process. Novartis will be discussing its breast cancer drug, alpelisib, which was approved in the US last May under the brand name Piqray.

In addition, D&A Pharma has been summoned for an oral explanation to discuss the negative opinion the EMA adopted last...

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