http://www.fiercebioresearcher.com/...s-pre-pandemic-vaccine-application/2008-06-19
June 19, 2008
By John Carroll
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.
June 19, 2008
By John Carroll
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.