The United States has delayed approval of a new antibiotic from Johnson & Johnson and Basilea, saying more clinical data are needed, the two companies said.
Ceftobiprole is a broad-spectrum antibiotic designed to kill the dangerous bacterium MRSA. The delay now looks likely to last at least six months, which sent both companies' shares down. The US Food and Drug Administration said the data on skin infections were unclear and needed to be reconciled between the two companies.
The drug is already approved in Switzerland and Canada and recommended for approval in the European Union. The rise of "superbugs" resistant to the antibiotics now used in hospitals has increased the demand for new antibiotics.
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