The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted and agreed to review applications seeking approval of AVT02, a Humira (adalimumab) biosimilar candidate. The FDA is expected to make a decision in September 2021,…
To empower and equip members of the rare disease community to engage state leaders in matters of importance to patients and their families, the National Organization for Rare Disorders (NORD) has launched an initiative across the U.S. Its goal is to establish a Rare Disease Advisory Council (RDAC)…
The first wave of COVID-19 in Europe severely disrupted access to care and raised stress and anxiety in people with rare diseases, negatively affecting their health and well-being, according to a survey conducted by Eurordis-Rare Diseases Europe. “People living with rare diseases in Europe have found themselves caught as collateral…
Leaders in the U.S. rare disease community came together recently for a webinar to present helpful information on how to start a nonprofit and patient registry. They shared about how their respective organizations came to be, as well as the benefits of creating patient registries and how they can help…
Treatment with Cimzia (certolizumab pegol) can ease eye inflammation in people with ankylosing spondylitis (AS), and reduce symptoms in those with active non-radiographic axial spondyloarthritis (nr-axSpA), new clinical trial data show. The data were presented by researchers from UCB — which markets Cimzia — and other institutions at…
Treatment with Xeljanz (tofacitinib) was found to significantly ease symptoms of ankylosing spondylitis (AS) in a Phase 3 clinical trial. The results are being presented today at ACR Convergence 2020, in a session titled “Tofacitinib for the Treatment of Adult Patients with Ankylosing Spondylitis: Primary Analysis…
The National Organization for Rare Disorders (NORD)’s RareLaunch training program will host two days of free virtual workshops in December, with the aim of empowering leaders to start non-profit organizations and research programs to help people with rare diseases. “The RareLaunch program is central to NORD’s mission and history — community…
Gilead Sciences has suspended enrollment in two Phase 3 trials studying the effects of filgotinib, an anti-inflammatory therapy currently being investigated in several inflammatory conditions, in patients with ankylosing spondylitis (AS). The trials, SEALION2-NAÏVE (NCT04483700) and SEALION1-IR (NCT04483687), set out to determine if filgotinib is potentially…
A photo of a bespectacled young boy, his red baseball cap slightly askew as he enjoys time outside, will be featured on the front cover of an upcoming calendar in the “Same But Different” contest to raise awareness about rare disorders. “A Lovely Day Out in Kew Gardens,”…
Treatment with Humira (adalimumab) increases work productivity, reduces sleep problems, and eases disease activity in people with ankylosing spondylitis (AS) and related diseases, a new real-world study indicates. The study, “Real-world evidence of the impact of adalimumab on work productivity and sleep measures in…
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