Author Archives: Ines Martins, PhD

RC18 Receives FDA’s Fast Track Designation for Treating SLE

The U.S. Food and Drug Administration (FDA) has granted fast track designation to RemeGen‘s RC18 (telitacicept) to treat people with systemic lupus erythematosus (SLE). A therapy candidate is put on the FDA’s fast track program if it can treat serious conditions and fill an unmet clinical need, either because no…

RemeGen Raises $100M to Advance Potential Lupus Treatment, RC18

RemeGen has received $100 million in private financing to continue advancing RC18 (telitacicept), its lead treatment candidate for autoimmune diseases like systemic lupus erythematosus (SLE) now in a pivotal clinical trial. The funding will also support the China-based company’s early stage treatment discovery platform, help expand its manufacturing…

Painful Skin Nodules Are Rare Manifestation of SLE in Children

Panniculitis — a group of conditions that causes painful bumps to appear under the skin — is a rare manifestation of childhood-onset systemic lupus erythematosus (cSLE) that occurs mainly in the first three years of disease, and seems to be an indicator of less severe systemic lupus, a study found.

FDA Gives Baricitinib Fast Track Status for SLE Treatment

The U.S. Food and Drug Administration has granted fast track status to baricitinib for the treatment of systemic lupus erythematosus (SLE) patients, the treatment’s developers, Eli Lilly and Incyte, announced. Fast track designation is intended to speed the therapy’s development and review for lupus patients, enabling more frequent communication with…