(IN BRIEF) Roche announced that its Phase III INShore trial evaluating Gazyva/Gazyvaro (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome met its primary endpoint, showing superior sustained remission rates at one year compared to mycophenolate mofetil (MMF). The … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged B cell targeting, Basel, Chronic kidney disease, corticosteroids, EMA, FDA, Gazyva, Gazyva/Gazyvaro Demonstrates Superior Sustained Remission in Children and Young Adults With Idiopathic Nephrotic Syndrome, Gazyvaro, idiopathic nephrotic syndrome, immune-mediated kidney diseases, INS, INShore study, Levi Garraway, lupus nephritis, NOBILITY study, obinutuzumab, pediatric nephrology, phase III clinical trial, proteinuria, REGENCY study, renal disease, Roche, Roche Announces Positive Phase III INShore Results for Gazyva/Gazyvaro in Children and Young Adults With Idiopathic Nephrotic Syndrome, sustained remission, targeted therapy
(IN BRIEF) Roche has received FDA approval for Gazyva/Gazyvaro (obinutuzumab) as a treatment for adult patients with active lupus nephritis, supported by data from the NOBILITY and REGENCY trials that showed significantly improved renal response compared with standard therapy. The … Read the full press release
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged anti-CD20 monoclonal antibody, autoimmune disease, autoimmune therapy, biopharmaceuticals, CHMP, European Medicines Agency, FDA approval, Gazyva, Gazyva/Gazyvaro Approved by FDA as First Anti-CD20 Therapy to Achieve Complete Renal Response in Lupus Nephritis, Gazyvaro, kidney disease, Levi Garraway, Louise Vetter, Lupus Foundation of America, lupus nephritis, nephrology, NOBILITY trial, obinutuzumab, REGENCY trial, renal response, Roche, Roche Basel, Roche Strengthens Autoimmune Portfolio with FDA Approval of Gazyva/Gazyvaro for Lupus Nephritis Treatment, systemic lupus erythematosus
In the pivotal study, treatment with Gazyvaro plus bendamustine chemotherapy reduced the risk of disease worsening or death by 52 percent compared to bendamustine alone BASEL, 04-May-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU … Read the full press release
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