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 …

Emergent BioSolutions Receives Orphan Drug Designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease

April 21, 2014 Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax® (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 …

Dynavax Initiates Phase 3 Study of HEPLISAV-B

April 15, 2014 Dynavax Technologies Corporation today announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study (known as HBV-23) was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the U.S. Food and Drug Administration in …