FDA cancels meeting on J&J’s ceftobiprole
FDA cancels the Anti-Infective Drugs Advisory Committee meeting scheduled for Feb. 28 to discuss Johnson & Johnson's NDA for the broad-spectrum cephalosporin antibiotic ceftobiprole. The committee will still meet on Feb. 27 to discuss Theravance's telavancin for the treatment of complicated skin and skin structure infection (1"The Pink Sheet," Jan. 14, 2008, In Brief)...
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Advisory committee to review two antibiotics
The Anti-Infective Drugs Advisory Committee will review Johnson & Johnson's ceftobiprole medocaril Feb. 27, and Theravance/Astella's telavancin Feb. 28. Committee discussion may center on the use of non-inferiority studies to support the applications for the treatment of complicated skin and skin structure infections; such designs are discouraged by draft FDA guidance, and the agency may want reassurance on efficacy questions (1"The Pink Sheet" Oct. 22, 2007, p. 17)...
EU Crunch Time For Mirikizumab, New Covid-19 Vaccine & Other Drugs
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back marketing approval for eight new drugs and a coronavirus vaccine.
European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.