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EmblemHealth, Inc. (“Emblem”) filed a class action suit in the District Court for the District of Massachusetts ...
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit issued a decision in the case of In Re: Xencor, Inc. In this Appeal from ...
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MedPage Today on MSNFDA Approves Nipocalimab for Adult and Pediatric Myasthenia GravisThe FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...
Soliris (eculizumab) was first approved for paroxysmal nocturnal hemoglobinuria (PNH) in 2007 under Alexion, which later became AstraZeneca’s rare disease unit after its $39 billion buyout in 2020.
Massachusetts lawsuit claims subsidiary of UK pharma company unlawfully re-patented eculizumab, resulting in overpayments of more than $2 billion.
In 2007, the US Food and Drug Administration (FDA) approved eculizumab (Soliris ®), a recombinant humanized monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Beyond ...
Nicholas J. Silvestri, MD, describes how this year’s AAN meeting highlighted significant advances in myasthenia gravis, including improved diagnostics through cell-based assays that enhance ...
Overall, data from 246 and 195 patients enrolled to 1 of 2 prior trials — comprising patients who were inhibitor naïve and who had received prior eculizumab, respectively — were included. Among ...
Teva Pharmaceuticals and Samsung Bioepis have announced the US launch of Epysqli (eculizumab-aagh), a biosimilar to the blockbuster biologic Soliris (eculizumab), following FDA approval for the ...
EPYSQLI ® (eculizumab-aagh) is now available to patients living with difficult-to-treat rare diseases like paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized ...
Both biosimilars treat several of the same rare immune diseases as Soliris. Amgen’s Bkemv and Teva/Samsung Bioepis’ Epysqli, biosimilars of Soliris (eculizumab), have launched at a discount to the ...
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