(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) AstraZeneca’s Alexion division has received FDA approval for Koselugo (selumetinib) to treat adults with NF1 who have symptomatic, inoperable plexiform neurofibromas. The decision is based on strong results from the Phase III KOMET trial, which showed a 20% … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged adult NF1 PN, Alexion, Annette Bakker, ASCO 2025, AstraZeneca, AstraZeneca Expands Koselugo’s Clinical Reach with New US Approval for Adults Living with Inoperable NF1 Plexiform Neurofibromas, Children’s Tumor Foundation, FDA approval, KOMET Phase III trial, Koselugo, Marc Dunoyer, MEK inhibitor, neurofibromatosis type 1, NF1, paediatric NF1 PN, Pierre Wolkenstein, plexiform neurofibromas, PN, rare disease treatment, regulatory approval, selumetinib, The Lancet, tumour response rate
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