Monoclonal Antibody

A biotechnology company announced the first patient was dosed in its phase 2a clinical trial of intranasal foralumab, a monoclonal antibody treatment for those with non-active secondary-progressive multiple sclerosis.

The FDA has granted fast track designation to Chemomab Therapeutics’ anti-CCL24 monoclonal antibody, CM-101, for the treatment of adults with primary sclerosing cholangitis, according to a manufacturer release.

A clinical-stage biotechnology company has been awarded a multiyear grant totaling $14.8 million from the National Institute on Drug Abuse to develop a subcutaneous formulation of an anti-fentanyl monoclonal antibody.

Ajovy significantly reduced depression symptoms and monthly migraine days in a phase 4 study, with clinically meaningful improvements in disability outcomes, manufacturer Teva Pharmaceuticals announced in a press release.

The FDA has issued a complete response letter for Eli Lilly and Company’s lebrikizumab biologics license application for moderate to severe atopic dermatitis treatment, according to a manufacturer-issued press release.

Nearly half a million Americans are diagnosed with Clostridioides difficile infection each year. Although often treated with antibiotics, C. difficile recurrence is possible. However, recently developed therapies may change this paradigm.

Treatment with neutralizing monoclonal antibodies in COVID-19 outpatients resulted in fewer hospital admissions and deaths vs. no antibody treatment, according to results published in CHEST.

The FDA on Monday approved a monoclonal antibody for the prevention of respiratory syncytial virus lower respiratory tract disease in newborn and infants.

An FDA advisory committee on Thursday voted in favor of approving the long-acting monoclonal antibody nirsevimab to protect neonates and infants from respiratory syncytial virus.