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Category: MS

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

• Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions • Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status • Affordable and small, instrument-free testing kit enables convenient use for healthcare professionals at […]

Novartis provides update on FDA review of ofatumumab

… a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing […]

Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe

• Reduces infusion time to 2 hours from the conventional 3.5 hours for patients with relapsing or primary progressive multiple sclerosis • EMA approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimen Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) […]

Novartis announces new late-breaking ofatumumab data

…at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS) Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no evidence of disease activity (NEDA-3) within the […]

New Late-Breaking Data at EAN Indicate Evobrutinib is the First BTK Inhibitor to Report Efficacy and Safety in MS Over 108 Weeks

• Investigational evobrutinib is the first and only Bruton’s Tyrosine Kinase inhibitor to demonstrate high and sustained efficacy through 108 weeks in clinical studies • No new safety signals identified in the 60 week open-label extension, consistent with data seen in more than 1,200 patients who have received evobrutinib to date, across MS and other […]