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

Suggested Articles

Ebola has claimed thousands of lives in recent outbreaks, but now the world has a licensed vaccine option in Merck's Ervebo.

Cosette Pharmaceuticals which was formed in December with a deal for dermatology projects has gone back to G&W Labs for a liquids plant.

Takeda has spent considerable resources on its phase 3 dengue vaccine, and now data show the shot was 80% effective in preventing dengue.