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Latest Content

Orphan Drug Designation for Argenx’s ARGX-113—Hopeful News for Myasthenia Gravis Community

On September 25, the FDA granted Orphan Drug Designation for Argenx’s lead clinical-stage product candidate, ARGX-113, for the treatment of myasthenia gravis (MG). The designation, which came one month after the EMA approval of the first complement-based therapy, Soliris, for the treatment of refractory generalized MG, is deemed welcoming and important news to the myasthenia gravis community, given the limited effective and sustainable treatments for this rare disease. ARGX-113 is also the second biologic that was granted the Orphan Drug Designation for the MG indication, and what makes this pipeline drug so attractive is that it targets a broader MG patient population, generalized MG (gMG), in comparison with Soliris’ smaller refractory gMG group, which is a clear bonus over its biologic competitor.

With $62M BARDA Contract Secured, the Future for Summit’s Ridinilazole Looks Bright

After being recently awarded a contract worth $62M from the US government’s Biomedical Advanced Research and Development Authority (BARDA), Summit Therapeutics has achieved a significant step toward initiating its clinical research program just seven months after outlining plans for Phase III trials for its developmental Clostridium difficile antibiotic, ridinilazole. With this news, the company looks well-positioned to kick-off its Phase III trials in H1 2018, thus securing ridinilazole’s position as the second most advanced developmental antibiotic for CDIs, behind Actelion’s cadazolid.

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