Merck announced yesterday that the FDA has approved ENFLONSIA (clesrovimab-cfor), a preventive monoclonal antibody, for the prevention of RSV lower respiratory tract disease in newborns and infants entering their first RSV season. ENFLONSIA is the only RSV preventative option that is administered with the same 105 mg dose regardless of the patient’s weight. It is…
Sanofi ramps up distribution of Beyfortus ahead of RSV season
Respiratory syncytial virus (RSV) already represents a blockbuster business with Sanofi reporting that Beyfortus (nirsevimab) hit global sales of €1.7 billion (roughly $1.77 billion) in its first full year on the market in 2024. Beyfortus protects infants from lung infections caused by RSV Beyfortus can help prevent a serious lung disease associated with RSV in…
Sanofi ALTUVIIIO hemophilia A treatment: FDA accepts sBLA based on pediatric phase 3 data
The FDA has accepted Sanofi’s supplemental Biologics License Application (sBLA) for ALTUVIIIO, a novel, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. The FDA based the decision on positive final data from the pivotal Phase 3 XTEND-Kids trial in children under 12 with hemophilia A. ALTUVIIIO (efanesoctocog alfa) is the first…
10x Genomics’ Chromium platform sheds light on CAR T-cell therapy persistence
Therapy persistence is a vital factor in determining the success of CAR-Ts for blood cancers like leukemia. While CAR-Ts hold great promise for blood cancers such as leukemia, in some cases, the durability of the treatment falls short, leading to a potential relapse. A positive study from researchers at University College London, Great Ormond Street…
FDA grants priority review of aflibercept in retinopathy of prematurity
Regeneron Pharmaceuticals (Nasdaq:REGN) has announced that the FDA has granted Priority Review of the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection to treat retinopathy of prematurity (ROP) in preterm infants. First approved in 2011 to treat wet age-related macular degeneration, aflibercept is a blockbuster drug. Last year, it generated $9.2 billion for Regeneron…