SK bioscience and Sanofi have announced positive results from the Phase II study of their 21-valent pneumococcal conjugate vaccine candidate, GBP410 (also known as SP0202). The vaccine demonstrated positive safety and immunogenicity data in infants. The companies plan to start Phase III trials in the first half of 2024. The Phase II clinical trial evaluated the safety and immunogenicity of GBP41..
Inozyme Pharma, a clinical-stage rare disease biopharmaceutical company, has announced the dosing of the first infant with ENPP1 Deficiency in a Phase 1b trial of their drug, INZ-701. The trial, called ENERGY-1, aims to assess the safety and effectiveness of INZ-701 in infants with this condition. ENPP1 Deficiency is a progressive condition that can lead to severe symptoms and high mortality rat..
AstraZeneca and Sanofi have received unanimous backing from the FDA’s Antimicrobial Drugs Advisory Committee for their respiratory syncytial virus (RSV) antibody, nirsevimab, for use in the pediatric setting. Nirsevimab is an investigational long-acting antibody that targets and binds to the part of the RSV virus that attaches to the host’s cells. If approved, nirsevimab would become the first i..
Pharmaceutical companies AstraZeneca and Sanofi have received unanimous approval from the FDA's Antimicrobial Drugs Advisory Committee for their respiratory syncytial virus (RSV) antibody, nirsevimab, to be used in pediatric settings. The committee voted 21-0 in favor of approving the immunizing antibody for use in infants during their first RSV season, while also recommending its approval for h..
