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SB12, Samsung Bioepis’ biosimilar candidate of Soliris (eculizumab), is comparable to the original medication in terms of safety, pharmacological properties, and immunoreactivity profile, according to data from a Phase 1 clinical trial in healthy volunteers. Soliris, by Alexion Pharmaceuticals, is an approved therapy for a number of conditions,…
Prior treatment with rituximab does not limit the effectiveness or safety of Uplizna (inebilizumab-cdon) in people with  neuromyelitis optica spectrum disorder (NMOSD), a further analysis of data from the N-MOmentum Phase 2/3 trial has found. Uplizna’s efficacy in preventing NMOSD attacks and its safety profile were comparable in trial…
The National Organization for Rare Disorders (NORD) asks Americans to plan ahead to participate in the Light Up for Rare campaign to raise awareness of rare diseases. NORD is the U.S. sponsor for Rare Disease Day on Feb. 28. The annual awareness day spotlights approximately 7,000…
Merck KGaA will continue to advance CRD1 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG), after the company acquired the therapy’s original developer, Chord Therapeutics. The investigational therapy is an oral cladribine product that works by reducing the number of immune cells, namely…
Long-term treatment with Uplizna (inebilizumab-cdon) safely and effectively reduced the frequency of attacks in the 12 neuromyelitis optica spectrum disorder (NMOSD) patients who were negative for antibodies against aquaporin-4 (AQP4) in the N-MOmentum Phase 2/3 trial. Future, appropriately-controlled studies are needed to confirm Uplizna’s benefits in this subgroup…
The Sumaira Foundation (TSF) has awarded five $25,000 grants to projects seeking to advance research into preventing, treating, and potentially curing neuromyelitis optica spectrum disorder (NMOSD). This year’s awards — four SPARK grants and one Unicorn grant — will help researchers initiate projects focused on: biomarkers…
Uplizna (inebilizumab-cdon), a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD), is now available in the U.S. through specialty distributor BioCareSD and specialty infusion pharmacy BioTek Remedys. The companies added the medication to their portfolio of specialty therapeutics to expand upon their product offering…
A committee of the European Medicines Agency has recommended approving Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who test positive for aquaporin-4 water channel autoantibodies (AQP4-IgG). This recommendation from the Committee for Medicinal Products for Human Use, known as CHMP, will now be reviewed by…
Over 230 national organizations signed a letter urging all 50 U.S. state governors to “maintain and expand” flexibility with licensure requirements for the duration of the COVID-19 pandemic to ease access to care. During the pandemic, governors used emergency authority to waive certain state licensure requirements, giving healthcare providers…
Uplizna (inebilizumab-cdon) safely prevented autoimmune attacks in 83% of people with neuromyelitis optica spectrum disorder (NMOSD) who received the treatment for four or more years, data from the N-MOmentum Phase 2/3 clinical trial show. Among those who experienced relapses, most did so during the first year of treatment.
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