(IN BRIEF) Sanofi has obtained orphan drug designation in Japan for rilzabrutinib as a treatment for IgG4-related disease, a rare immune-mediated condition with limited treatment options. The designation from Japan’s Ministry of Health, Labour and Welfare is supported by positive … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Technology
Tagged Bruton tyrosine kinase inhibitor, BTK inhibitor, IgG4-RD, IgG4-related disease, immune thrombocytopenia, immune-mediated diseases, ITP, MHLW, Ministry of Health Labour and Welfare Japan, orphan drug designation, phase 2 clinical trial NCT04520451, rare disease treatment, rare diseases, rheumatology, RILIEF phase 3 study NCT07190196, rilzabrutinib, Sanofi, Sanofi Expands Global Regulatory Recognition of Rilzabrutinib for Rare Immune Mediated Diseases, Sanofi Secures Japanese Orphan Drug Status for Rilzabrutinib Following Positive Clinical Study Results, SCD, sickle cell disease, wAIHA, warm autoimmune hemolytic anemia
(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) Rilzabrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, has received orphan drug designation from the U.S. FDA for sickle cell disease. This marks the fourth such designation for the drug, which has already been recognized for its potential … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged BTK inhibitor, fast track status, FDA, IgG4-related disease, immune thrombocytopenia, multi-immune modulation, orphan drug designation, preclinical data, rare diseases, rilzabrutinib, Sanofi, sickle cell disease, Tailored Covalency®, vaso-occlusive crises, warm autoimmune hemolytic anemia
Project Africa GRADIENT calls on local researchers to submit proposals exploring the link between genetic diversity and response to malaria and tuberculosis drugs in African patients. Combined funding commitment of GBP 2.8 million (USD 3.6 million) over five years. Researchers … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Society, Switzerland, United Kingdom
Tagged Africa, African genetic diversity, Chagas disease, drug therapeutics, genetic diversity, Genomic, GSK, Human genetics, Leprosy, Lutz Hegemann M.D., malaria, Novartis, Pauline Williams, Prof. Glenda Gray, Project Africa GRADIENT, SAMR, scientific research, sickle cell disease, South African Medical Research Council, therapeutics, tuberculosis
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