(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
(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
(PRESS RELEASE) PARIS, 28-Aug-2020 — /EuropaWire/ — French multinational pharmaceutical company Sanofi announces its intention to commence a tender offer (the “Offer”) to acquire all of the outstanding shares of common stock of Principia Biopharma Inc. for $100 per share … Read the full press release
Posted in France, Healthcare, News, Pharma & Biotech
Tagged acquisition, biopharmaceutical, BofA Securities, BTK inhibitor, Centerview Partners LLC, Cooley LLP, Evercore, Gotshal & Manges LLP, Healthcare, immune thrombocytopenia, immune-mediated diseases, ITP, Kortex Acquisition Corp., MERGER, Merger Agreement, outstanding shares, Principia Biopharma Inc., rilzabrutinib, Sanofi, stock, Tailored Covalency®, tender offer, Weil
Further strengthens core R&D areas of autoimmune and allergic diseases Provides full control of brain-penetrant BTK inhibitor SAR442168 in multiple sclerosis (MS), making commercialization more efficient and eliminating future royalty payments Allows expansion of SAR442168 development program into other central … Read the full press release
Posted in Business, France, Healthcare, Investment, News, Pharma & Biotech
Tagged acquisition, allergic diseases, Arnaud Delepine, Ashleigh Koss, autoimmune diseases, biopharmaceutical, BofA Securities, Bruton tyrosine kinase, BTK inhibitor, BTK inhibitor ‘168, Centerview Partners LLC, Christopher Chai, commercialization, Cooley LLP, Eva Schaefer-Jansen, Evercore, Fara Berkowitz, Felix Lauscher, Gotshal & Manges LLP, John Reed M.D. Ph.D., Martin Babler, MS, multiple sclerosis, Nicolas Kressmann, pathophysiology, Paul Hudson, Paul Laland, Pharmaceutical, Principia, Principia Biopharma, PRN473 Topical, rilzabrutinib, Sanofi, SAR442168, Suzanne Greco, Weil, Yvonne Naughton
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