Pfizer’s Investigational Vaccine Candidate for Clostridium difficile Receives U.S. Food and Drug Administration Fast Track Designation

August 28, 2014 Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis. “C. difficile is a growing, difficult-to-treat healthcare-associated infection,” said Dr. Emilio …

Sanofi Pasteur Announces Favorable Phase II Study Results for Investigational Clostridium difficile Vaccine at the American Society for Microbiology Meeting

Results indicate vaccine generates an immune response against key toxins in volunteers and establish dosing for Phase III May 19, 2014 Sanofi Pasteur, the vaccines division of Sanofi , presented Phase II trial (H-030-012) results for an investigational vaccine for the prevention of Clostridium difficile (C. diff) infection (CDI) at the 114th General Meeting of the American Society for Microbiology …