Basilea gets FDA request for more data on pneumonia drug

FDA

Basilea Pharmaceutica AG, a Swiss developer of an antibiotic to treat pneumonia, said the U.S. Food and Drug Administration asked for more data before approving the drug. The stock fell as much as 12 percent.

Basilea doesn’t plan to start the new late-stage clinical trials of its ceftobiprole without a partner for the U.S., the Basel-based company said in a statement today.

The decision is a setback for ceftobiprole, which will become available in some European markets in the second half of this year. The drugmaker had been in talks with “many” companies for a partnership and plans to contact them again now that the FDA’s guidance is clear, Chief Executive Officer Ron Scott said in a phone interview.

For more details, go to: http://www.bloomberg.com/news/2014-06-25/basilea-gets-fda-request-for-more-data-on-pneumonia-drug.html

Michael Wonder

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Michael Wonder

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