(IN BRIEF) AstraZeneca has secured FDA approval for a new subcutaneous autoinjector version of Saphnelo, enabling once-weekly self-administration for adults with systemic lupus erythematosus. The approval is based on Phase III trial results showing significant reductions in disease activity compared … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anifrolumab, AstraZeneca, AstraZeneca introduces new subcutaneous Saphnelo delivery method to improve convenience and outcomes in lupus care, autoimmune disease, autoinjector, biologic therapy, Bristol-Myers Squibb, clinical trials, FDA, Healthcare Innovation, Louise Vetter, Lupus Foundation of America, Medarex, Ruud Dobber, Saphnelo, SLE, Susan Manzi, systemic lupus erythematosus, TULIP-SC, U.S. Food and Drug Administration
(IN BRIEF) Roche has reached a key regulatory milestone with the FDA’s acceptance of its application for Gazyva/Gazyvaro as a treatment for systemic lupus erythematosus. The submission is based on strong phase III trial data showing significant improvements in disease … Read the full press release
Posted in Healthcare, Industrial, Pharma & Biotech, Science, Switzerland, Technology
Tagged Albert T. Roy, ALLEGORY study, anti-CD20 therapy, autoimmune disease, B cells, biologics, clinical research, disease activity, FDA, FDA Filing Acceptance Marks Significant Step for Roche in Developing Targeted Therapy for Lupus Patients, Gazyva, Gazyvaro, Healthcare Innovation, immunology, Levi Garraway, lupus nephritis, Lupus Research Alliance, obinutuzumab, Phase III Trial, remission, Roche, Roche Advances New Treatment Option for Lupus as FDA Accepts Filing for Gazyva Based on Phase III Data, SLE, systemic lupus erythematosus, U.S. Food and Drug Administration
(PRESS RELEASE) CAMBRIDGE, 16-Feb-2022 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced an European Union (EU) approval for its Saphnelo (anifrolumab) medicine as an add-on therapy for the treatment of adult patients with … Read the full press release
(PRESS RELEASE) CAMBRIDGE, 2-Aug-2021 — /EuropaWire/ — AstraZeneca (LON: AZN), a British-Swedish science-led biopharmaceutical company, has announced that its Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus … Read the full press release
Posted in Healthcare, Marketing, News, Science, Technology, United Kingdom
Tagged AstraZeneca, bronchitis, corticosteroid, cough, cutaneous lupus erythematosus, Dr. Richard Furie, FDA, herpes zoster, infusion-related reactions, lupus, lupus nephritis, Mene Pangalos, MUSE Phase II trial, myositis, nasopharyngitis, OCS, oral corticosteroid, pathophysiology of lupus, Saphnelo, SLE, systemic lupus erythematosus, therapy, TULIP Phase III trials, type I IFN, type I interferon, upper respiratory tract infection
LONDON, 22-Mar-2018 — /EuropaWire/ — GSK today announced the start of a phase III study investigating Benlysta (belimumab) in combination with rituximab in adult patients with systemic lupus erythematosus (SLE). Belimumab and rituximab have different but potentially complementary mechanisms of action. … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged belimumab, Gijs van den Brink, GSK, lupus, rituximab, SLE, systemic lupus erythematosus
Final efficacy and safety results from phase II continuation study Madrid, Spain and London, UK, 19-Jun-2017 — /EuropaWire/ — GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease … Read the full press release
Posted in Healthcare, Pharma & Biotech, Spain, United Kingdom
Tagged Benlysta, David Roth, GSK, SLE, systemic lupus erythematosus
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