News

New Streaming Channel Showcases Rare Disease Films

When the COVID-19 pandemic forced the postponement of a rare disease film festival originally slated for May, its organizers set out to find a new way to bring the films to an audience.  Co-founders Daniel DeFabio and Bo Bigelow, who are both fathers of children with…

nr-axSpA Given Diagnostic Code on International Classification of Diseases

Non-radiographic axial spondyloarthritis (nr-axSpA) has been given a diagnostic code, M46.80, that will be used to identify the condition in the 10th edition of the International Classification of Diseases, Clinical Modification (ICD-10-CM), a repository that contains the official codes of all types of diseases. The updated ICD-10-CM document containing…

Hulio, Humira Biosimilar, Approved But Not Available Until 2023

The U.S. Food and Drug Administration (FDA) has approved Hulio, a biosimilar of Humira (adalimumab), to treat chronic inflammatory disorders such as ankylosing spondylitis. However, Hulio (adalimumab-fkjp) — developed by Mylan and Fujifilm Kyowa Kirin Biologics — will not be available in the U.S. until July 31,…

CHMP Favors At-home Injection Form of Remsima for Europe

The Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), is recommending the use of a subcutaneous (under the skin) injection formulation of Remsima (infliximab) by people with ankylosing spondylitis and four other disorders. Celltrion Healthcare designed this new version…