(IN BRIEF) Sanofi has received FDA priority review for the new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor being developed for type 3 Gaucher disease. The FDA’s target action date is 25 November 2026. If approved, venglustat … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged adult patients, ataxia, biopharma, blood-brain barrier, breakthrough therapy designation, central nervous system, cerebrospinal fluid, cognitive deficits, enzyme replacement therapy, ERT, EURONEXT: SAN, Fabry disease, Fast Track Designation, FDA, Gaucher disease, GCSi, GD3, GL1, glucosylceramide synthase inhibitor, glycosphingolipids, GSL, haemoglobin, LEAP2MONO, liver volume, lyso-GL1, lysosomal storage disease treatments, lysosomal storage disorder, Nasdaq SNY, NCT05222906, NDA, neuroinflammation, neurological manifestations, New Drug Application, orphan designation, paediatric patients, Paris, phase 3 study, platelet count, Priority Review, rare diseases, Sanofi, Sanofi Builds Rare Disease Pipeline as FDA Accepts Venglustat Application for Priority Review in GD3, Sanofi’s Venglustat Could Become First U.S. Treatment Targeting Neurological Symptoms of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Potential Treatment of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Type 3 Gaucher Disease Treatment in the United States, spleen volume, type 3 Gaucher disease, U.S. Food and Drug Administration, venglustat, WORLDSymposium
(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
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