(IN BRIEF) Sanofi’s Tzield has been accepted for priority review by the U.S. Food and Drug Administration to expand its use to children aged one year and older with stage 2 type 1 diabetes. The submission is supported by interim … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autoimmune disease, beta cell protection, Christopher Corsico, clinical development, disease modifying therapy, FDA priority review, pediatric diabetes, pediatric endocrinology, PETITE T1D study, regulatory review, Sanofi, Sanofi’s Tzield Receives FDA Priority Review for Use in Young Children with Stage 2 Type 1 Diabetes, stage 2 T1D, teplizumab mzwv, type 1 diabetes, TZIELD
(IN BRIEF) Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), two rare conditions with no approved treatments. This designation, aimed at addressing unmet … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged BTK inhibitor, clinical trials, FDA, IgG4-RD, IgG4-related disease, immune thrombocytopenia, ITP, multi-immune modulation, orphan drug designation, phase 2a study, phase 2b study, rare diseases, regulatory review, rilzabrutinib, Sanofi, unmet medical need, wAIHA, warm autoimmune hemolytic anemia
(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release
Posted in Business, European Union, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADRIATIC Phase III trial, AstraZeneca, CHMP, disease progression, durvalumab, EMA, European Medicines Agency, hazard ratio, Imfinzi, immunotherapy, limited-stage small cell lung cancer, LS-SCLC, monotherapy, overall survival, platinum-based chemoradiation therapy, progression-free survival, regulatory review, safety profile, Small cell lung cancer, Suresh Senan, survival outcomes, Susan Galbraith, The New England Journal of Medicine, treatment approval
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