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J&J/Basilea’s Ceftobiprole NDA Edges Ahead

This article was originally published in The Pink Sheet Daily

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Executive Summary

“Approvable” word from FDA represents a victory in tough antibiotic field.

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J&J/Basilea's Ceftobiprole Faces Another Setback

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

J&J/Basilea's Ceftobiprole Faces Another Setback

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

J&J/Basilea’s Ceftobiprole Gets Another Setback

FDA stops the investigational antibiotic’s six-month review clock for additional clinical site audits, data integrity review.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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