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Basilea drug receives US FDA qualified infectious disease product designation

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Basilea drug receives US FDA qualified infectious disease product designation

Basilea Pharmaceutica AG said the U.S. Food and Drug Administration granted qualified infectious disease product designation to its investigational drug ceftobiprole.

The cephalosporin antibiotic is intended to combat staphylococcus aureus bacteria, the leading cause of bloodstream infections.

The designation provides certain incentives for the development of antibiotics, such as priority review and a five-year market exclusivity extension should ceftobiprole be approved.

Basilea said it is preparing two phase 3 trials of the drug to support potential future registration in the U.S.