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Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Novartis has gotten extension from FDA for its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

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Novartis data highlight benefit of early treatment initiation in patients with secondary progressive multiple sclerosis (SPMS)

Data from Phase III EXPAND trial, continue to build on existing clinical evidence that Mayzent has significant impact on reducing the risk of disease progression, including physical disability and cognitive decline for patients with SPMS.

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Biogen, Alkermes get approval for Vumerity in USA, to treat relapsing forms of MS

Biogen and Alkermes got approval from USFDA for Vumertiy, a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

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Merck Initiates Pivotal Phase III Programme for Investigational Evobrutinib in Relapsing Multiple Sclerosis

Merck, a leading science and technology company, today announced the initiation of two global pivotal Phase III trials (EVOLUTION RMS 1 and 2) studying the efficacy and safety of evobrutinib, an oral, highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS).

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