FDA delays J&J antibiotic

Shares of Switzerland's Basilea Pharmaceutica were hammered after the developer announced that it faced a major delay in gaining an approval from the FDA for its antibiotic ceftobiprole [1]. In a letter to Johnson & Johnson Pharmaceutical Research and Development, the FDA raised questions about data integrity from its clinical program for the antibiotic. J&J is partnered on the drug. The FDA wants further auditing of its clinical sites and more information on J&J's quality assurance program. Report [2]