PaxVax Announces Primary Endpoints Met in Phase 3 Cholera Vaccine Trial

Positive Lot-to-Lot Consistency Data Pave Way for Biologics License Application (BLA) Submission in 2015 December 8, 2014 PaxVax Inc., a specialty vaccine company focused on travel and biodefense, today announced positive results from a Phase 3 safety and lot-to-lot consistency trial of its single-dose oral cholera vaccine candidate, PXVX0200, which utilizes the same attenuated vaccine strain (CVD 103-HgR) previously approved …

Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine

June 17, 2014 Pfizer Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. Each year, approximately 500,000 cases of meningococcal disease occur worldwide …

Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero(R) to help protect US adolescents and young adults

Submission follows receipt of Breakthrough Therapy designation in April 2014, highlighting unmet need for a licensed vaccine for serogroup B in the US[1] Meningitis B is a rare but aggressive disease that can kill or cause serious life-long disability within 24 hours of onset, often with initial flu-like symptoms[2],[3],[4] Bexsero, approved in 34 countries, was recently provided to two US …