First Treatment Approved for Genetic Clotting Disorder
The U.S. Food and Drug Administration has approved a recombinant ADAMTS13 protein product (Adzynma) as a prophylactic or on-demand enzyme replacement therapy for patients with congenital thrombotic thrombocytopenic purpura.
First Vaccine for Mosquito-Born Viral Disease Is Approved by FDA
The U.S. Food and Drug Administration has approved IXCHIQ, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
FDA Approves Zepbound as a New Weight-Loss Drug
The U.S. Food and Drug Administration has approved Eli Lilly’s tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well.
New Vaccine Could Fight Hospital-Acquired Infections by Boosting the Immune System
A new type of vaccine could stimulate the innate immune system to prevent deaths from hospital-acquired infections (HAIs) caused by a variety of bacteria and fungi, according to a recent study.
Efgartigimod Efficacious in Treating Chronic Immune Thombocytopenia
A new study shows efgartigimod significantly increased sustained platelet count responses compared with placebo in patients with chronic immune thrombocytopenia, including those who had received multiple previous immune thrombocytopenia therapies.
Study Shows Positive Results for mRNA-Based Combination Influenza and COVID-19 Vaccine
A Phase I/II study evaluating the safety, tolerability and immunogenicity of Pfizer and BioNTech’s mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age show positive topline results.
Complement C5 Inhibitor Zilucoplan Is Approved by FDA to Treat MG
UCB Pharma’s investigational agent zilucoplan, a complement C5 inhibitor, to treat patients with myasthenia gravis has been approved by the U.S. Food and Drug Administration under the market name Zilbrysq.
IVIG Reduces Infection Risk During Anti-BCMA Treatment for MM
Data suggests the bispecific BCMA-targeted antibody teclistamab may lead to grade 3 to 5 infections in as many as 44.8 percent of multiple myeloma patients, and hypogammaglobulinemia was noted in nearly 75 percent of patients.
Intranasal COVID-19 Vaccine Shows High Seroresponse
A Phase I randomized, double-blind, placebo-controlled dose-escalation study in healthy adults, called CDX-CoV-001, has found Codagenix’s intranasal COVID-19 vaccine candidate, CoviLiv, showed the vaccine had a high seroresponse rate and induced mucosal immunity in volunteers not previously vaccinated or infected.
Moderna’s Influenza-COVID-19 Vaccine Demonstrates Immunogenecity
Results from Moderna’s Phase I/II clinical trial that evaluated the safety and immunogenicity of its influenza-COVID-19 vaccine, mRNA 1083, showed immunogenicity against all four influenza strains compared to a standard dose of the influenza vaccine, Fluarix, in adults 50 to 64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65 to 79 years of age.