(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for rilzabrutinib (Wayrilz) in warm autoimmune hemolytic anemia, based on data from the ongoing LUMINA 2 … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Breakthrough Therapy, BTK inhibitor, clinical trials, FDA, FDA Grants Breakthrough Status to Sanofi’s Rilzabrutinib for Rare Blood Disorder, IgG4-related disease, immune thrombocytopenia, Japanese Ministry of Health Labour and Welfare, Karin Knobe, LUMINA 2, LUMINA 3, orphan drug, rare diseases, rilzabrutinib, Sanofi, Sanofi Advances Rilzabrutinib with Breakthrough and Orphan Designations in wAIHA, sickle cell disease, Tailored Covalency®, wAIHA, warm autoimmune hemolytic anemia, Wayrilz
(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech, Technology
Tagged advanced endometrial cancer, antibody-drug conjugate, BioNTech SE, BNT323, Breakthrough Therapy, DB-1303, Duality Biologics, DualityBio, endometrial cancer, FDA, HER2, Human Epidermal Growth Factor Receptor 2, Prof. Özlem Türeci M.D., uterine cancer, Vivian Gu M.D.
Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine to show superior efficacy compared to prior factor VIII prophylaxis in an intra-patient comparison BASEL, 19-Apr-2018 — /EuropaWire/ — Roche … Read the full press release
Posted in Healthcare, Netherlands, Pharma & Biotech, Switzerland
Tagged Breakthrough Therapy, haemophilia, Hemlibra, inhibitors, medicines, Roche, Sandra Horning MD
Investigational Enzyme Replacement Therapy to Treat Non-Neurological Manifestations which characterize Niemann-Pick Type B PARIS, 5-6-2015 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olipudase alfa. … Read the full press release
Posted in France, Pharma & Biotech, Science
Tagged Breakthrough Therapy, Genzyme, Niemann-Pick Type B, olipudase alfa, Richard Peters, Sanofi, sphingomyelin, US FDA
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