News

FDA grants breakthrough therapy status to nipocalimab for Sjögren’s disease

Johnson & Johnson’s antibody-based therapy candidate nipocalimab has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for treating adults with moderate to severe Sjögren’s disease. This status is meant to accelerate the development and regulatory review of investigational therapies intended to treat serious…

Experimental Sjögren’s therapy shows potential in early lab studies

KB-7898, Kronos Bio’s investigational therapy for Sjögren’s disease, was shown to lower antibody production and the release of inflammatory molecules in lab studies involving cell and animal models of autoimmune conditions, the company announced. Kronos is planning further preclinical studies to assess KB-7898’s safety and pharmacological properties…

Lip biopsy with auxiliary device may diagnose Sjögren’s with fewer complications

Lip salivary gland biopsy using an auxiliary device called chalazion forceps may diagnose primary Sjögren’s disease as accurately as the conventional method, but with fewer procedure-related complications, a study suggests. Researchers noted that, compared with the conventional method, “the modified [lip salivary gland biopsy] … offers a good safety…