(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 announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AstraZeneca, Breast Cancer Treatment, Dave Fredrickson, Faslodex, Japan, Masakazu Toi, MHLW, safety, Truqap
(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science
Tagged ALTUVIIIO, authorization, bleeding, Brian Foard, efanesoctocog alfa, FDA, hemophilia A, Japan, marketing, MHLW, partnership, Sanofi, Sobi, treatment
LONDON, 29-Mar-2016 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE:GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately … Read the full press release
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