Industry News
Research, Science & Manufacturer Updates
A group of outside advisers to the Centers for Disease Control and Prevention (CDC) voted 5-2 to recommend the use of Merck’s new antibody vaccine, Enflonsia (clesrovimab), that can protect babies from respiratory syncytial virus (RSV).
A new clinical trial shows a single shot of a long-lasting influenza (flu) drug may protect people for an entire season, and it might do so more effectively than vaccines.
Grifols announced positive results from its Phase II/III clinical trial evaluating the efficacy and safety of Flebogamma 5% DIF (intravenous immune globulin [IVIG]) to treat patients with post-polio syndrome, which demonstrated a significant improvement in distance walked compared to placebo.
In a late-stage trial, Novavax's experimental COVID-19-influenza combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) vaccines generated a strong immune response in adults aged 65 and older, similar to already approved vaccines against the viruses.
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1) as determined by an FDA-approved test.
A recent study that sought to evaluate the efficacy of intravenous immune globulin (IVIG) and identify predictors of platelet response in pregnant persons with moderate-to-severe thrombocytopenia, as well as to optimize clinical decisions and resource use, has found that IVIG effectively increases platelet counts.
Scientists at Ohio State University have created an antibody that was successful in protecting a majority of the tested mice from lethal influenza (flu) doses, even preventing some from experiencing any symptoms at all.
Roche’s novel antibiotic zosurabalpin is entering Phase III testing to determine its effectiveness in protecting against carbapenem-resistant Acinetobacter baumannii (CRAB), am antimicrobial resistance (AMR) drug, or “superbug,” that is considered an “urgent threat” by the Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration has given marketing clearance to the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, a blood test to help diagnose Alzheimer’s disease for adults 55 and older who are showing signs and symptoms of the disease. It is the first test to be approved to aid in the early detection of the disease in the United States.
After a six-week delay, the U.S. Food and Drug Administration approved Novavax’s COVID-19 vaccine, but only for people 65 and older and those 12 years and older who have at least one underlying condition, such as asthma, diabetes, lung disease, obesity and pregnancy, that puts them at higher risk of severe illness.
A recent study of Moderna’s combination influenze (flu) and COVID-18 vaccine, mRNA-1083, found that it induced higher immune responses than recommended standard care influenza (standard and high dose) and COVID-19 vaccines against all four influenza strains (among those ages 50 to 64 years), the three clinically relevant influenza strains (among those aged 65 years and older), and SARS-CoV-2 (all ages), with an acceptable tolerability and safety profile.