(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 BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Ambition Zero Carbon, AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, Breztri, BTK inhibitor, budesonide, Calquence, chemoimmunotherapy, CHMP, chronic lymphocytic leukaemia, climate action in pharma, clinical trial, CLL, COPD, Dave Fredrickson, EMA, environmental sustainability, European approval, European Commission approval, European Union, fixed-duration regimen, formoterol fumarate, Frederik Trinkmann, glycopyrronium, hematologic diseases, hematology, Honeywell, inhalers, leukemia, low GWP, next-generation propellant, obinutuzumab, oncology, pMDI, progression-free survival, Respiratory Care, Ruud Dobber, Susanna Palkonen, Sustainable Healthcare, treatment option, Trixeo Aerosphere, venetoclax
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
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