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FDA Wants More Ceftobiprole Data From J&J/Basilea

This article was originally published in The Pink Sheet Daily

Executive Summary

Racing against Theravance's "approvable" telavancin, company will supply added results in diabetic foot infections.

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Basilea Takes On Partner J&J In Arbitration Claim Over Ceftobiprole Delays

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A Nov. 26 FDA complete response letter to Johnson & Johnson and Basilea Pharmaceutica for their antibiotic ceftobiprole cites deficiencies of study conduct and requests further clinical site audits

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