Theravance Trims Loss, CEO “Optimistic” About FDA Panel Ahead
This article was originally published in The Pink Sheet Daily
Executive Summary
Feb. 27 brings first test of noninferiority’s importance to regulators, analyst tells “The Pink Sheet” DAILY.
You may also be interested in...
FDA Advisory Panel Considers Trial Designs For Community Acquired Pneumonia
Non-inferiority margins in anti-infectives trials, product development topics on schedule for April meeting.
FDA Anti-Infective Drugs Advisory Committee To Review Two Antibiotics
Johnson & Johnson’s ceftobiprole and Theravance’s telavancin will be discussed Feb. 27-28.
Pfizer Receives “Approvable” Letter For MRSA Antibiotic Dalbavancin
Broad range of issues - from trial design to manufacturing - must be addressed before firm can add product to its antibiotic portfolio.