(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Ambition Zero Carbon, AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, Breztri, BTK inhibitor, budesonide, Calquence, chemoimmunotherapy, CHMP, chronic lymphocytic leukaemia, climate action in pharma, clinical trial, CLL, COPD, Dave Fredrickson, EMA, environmental sustainability, European approval, European Commission approval, European Union, fixed-duration regimen, formoterol fumarate, Frederik Trinkmann, glycopyrronium, hematologic diseases, hematology, Honeywell, inhalers, leukemia, low GWP, next-generation propellant, obinutuzumab, oncology, pMDI, progression-free survival, Respiratory Care, Ruud Dobber, Susanna Palkonen, Sustainable Healthcare, treatment option, Trixeo Aerosphere, venetoclax
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
(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) Roche presented promising 96-week data from the Phase II FENopta study, showing that its investigational drug, fenebrutinib, significantly reduced relapse rates and prevented disability progression in patients with relapsing multiple sclerosis (RMS). The study revealed an annualized relapse … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Bruton’s tyrosine kinase, BTK inhibitor, clinical data, clinical research, clinical trial, data, disability, disability progression, fenebrutinib, FENopta, Levi Garraway, multiple sclerosis, Phase II, relapse rates, relapsing multiple sclerosis, RMS, Roche, treatment
(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 Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acalabrutinib, AstraZeneca, autologous hematopoietic stem cell transplantation, bendamustine, blood cancers, Bruton’s tyrosine kinase, BTK inhibitor, Calquence, chemoimmunotherapy, COVID-19, Dave Fredrickson, ECHO Phase III trial, FDA, global regulatory review, international markets, Lymphoma Research Foundation, mantle cell lymphoma, MCL, Meghan Gutierrez, Michael Wang, oncology, PFS, progression-free survival, Project Orbis, regulatory submission, rituximab, safety profile, U.S. approval
(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
The trial, called CALAVI, will assess the effect of Calquence on the exaggerated immune response of patients hospitalised with COVID-19 infection (PRESS RELEASE) CAMBRIDGE, 14-Apr-2020 — /EuropaWire/ — Pharmaceutical giant AstraZeneca to begin a randomised, global clinical trial to assess … Read the full press release
Posted in Healthcare, Science, Sweden, Technology, United Kingdom
Tagged assisted ventilation, AstraZeneca, best supportive care, blood cancers, Bruton’s tyrosine kinase, BSC, BTK, BTK inhibitor, CALAVI, Calquence, clinical trial, COVID-19, cytokine storm, exaggerated immune response, inflammatory cytokines, José Baselga, Louis M. Staudt M.D. Ph.D., lung disease
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