French specialty vaccine company Valneva and U.S. drugmaker Pfizer reported positive results from the companies’ Phase II study on a vaccine candidate for Lyme disease.
Phathom Pharmaceuticals Inc. submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori infection in adults.
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.
Klick Health and Lakeridge Health introduced a technologically advanced medication dosage calculator to help pharmacists and physicians determine the correct amount of vancomycin for treating life-threatening, antibiotic-resistant, bacterial infections.
Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.
The U.S. Food and Drug Administration approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections in pediatric patients as young as newborns.
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.
PerkinElmer Inc. expanded the company’s presence in cell biology with the $260 million acquisition of Massachusetts-based Nexcelom Bioscience.