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ilgotinib Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency ....
Mechelen, Belgium, 27 May 2021, 22:01 CET, - Galapagos NV (Euronext & Nasdaq: GLPG) today announced that 15 abstracts, including scientific updates, and data providing further understanding on the ....
in clinical practice. The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes (PROs) in patients with moderate to severe active RA while receiving filgotinib in a real-world setting for up to two years. Mobile device technology will play a central role in collection of PROs, allowing data collection to begin within the first weeks of treatment. This may also prove to be an effective tool during the pandemic, while in-person clinic visits are harder to achieve. FILOSOPHY will enable the gathering of comprehensive real-world data in a population that may not be fully represented in clinical trials, as randomized, placebo-controlled trials require strict patient inclusion criteria. These data will expand the evidence base to support the appropriate use of filgotinib in clinical practice. ....
Galapagos NV: Galapagos announces first patient enrolled in FILOSOPHY study to advance understanding of Jyseleca (filgotinib) effectiveness and safety in a real-world setting - Mechelen that the first patient has been enrolled i . The goal with patients with in clinical practice. The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes (PROs) in patients with moderate to severe active RA while receiving filgotinib in a real-world setting for up to two years. Mobile device technology will play a central role in collection of PROs, allowing data collection to begin within the first weeks of treatment. This may also prove to be an effective tool during the pandemic, while in-person clinic visits are harder to achieve. ....