The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for Merck’s supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children.
Global biopharmaceutical firm Merck announced that the company’s Phase III trial for a potential treatment for pneumococcal disease in infants succeeded in meeting key safety, tolerability, and immunogenicity endpoints in the first 30 days.
The U.S. Food and Drug Administration approved Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
Data from a mid-stage clinical study of an experimental vaccine candidate developed by Affinivax and Astellas Pharma for Streptococcus pneumoniae shows ASP3772 is well tolerated and generated an antibody response against the deadly bacterial infection.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
Merck reported positive results regarding the safety, tolerability and immunogenicity in two Phase III studies for V114, the company’s investigational 15-valent pneumococcal conjugate vaccine.
Foster City, California-based SutroVax closed on a Series D preferred stock financing worth $110 million, which was co-led by new investors RA Capital Management and Janus Henderson Investors.
Pfizer announced positive results from two Phase III trials, one in moderate-to-severe atopic dermatitis and another in pneumococcal disease.
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), there are 264 vaccines in development to prevent and treat diseases.