Free Newsletter
Novartis yanks pre-pandemic vaccine application
Faced with a looming deadline to provide more data on the pre-pandemic vaccine Aflunov, Novartis Vaccines and Diagnostics has pulled its application for centralized marketing authorization from the European Medicines Agency. EMEA's Committee for Medicinal Products for Human Use has had the vaccine under review.
Novartis developed the product for use in advance of an outbreak of H5N1, but researchers said they needed more time to come up with the data needed for an approval. Regulators had discounted the data delivered in one study because they said the trial had not met their standard for good clinical practice.
"We will have to start again and generate new data, but we are convinced that a fresh application will be handed in in future," said a Novartis spokesman.
- read the report from Hemscott
Comments
Post new comment
Paid Research Reports
- The Specialty Pharma Market Outlook: Key players, new company growth models and emerging opportunities
- Investigating Clinical Trial Costs: Comparative analysis of trial cost components in key geographies
- Clinical Trial Recruitment Strategies: Optimizing patient recruitment and retention in late stage clinical trials
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession
