Pediatrics. NEJM 2020; 383: 415-425. European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants, Beyfortus is the first and only broadly protective option against RSV for newborns and infants, Results from the clinical development program reinforce Beyfortus consistency in reducing RSV infections requiring medical care, including hospitalizations. Press Release: European Commission grants first approval worldwide of Beyfortus (nirsevimab) for prevention of RSV disease in infants. (2020). Hammitt LL, MD et al. Studies were conducted in both hemispheres, at 164 sites in 23 countries.5,6Data was publishedin theNew England Journal of Medicine(NEJM)in July 2020. Orphan medicinal product designation in the European Union (EU) is granted by. Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S. Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development, FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma, Update from Sanofi regarding Kevzara (sarilumab): Supply constraints anticipated until early 2022, Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer, Dupixent (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease, New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia, New Soliqua data shows improved blood sugar control without weight gain versus premixed insulin, Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial, Dupixent (dupilumab) efficacy and quality of life data in asthma patients across multiple age groups to be presented at 2021 ERS international congress, Sanofi provides update on Phase 3 study evaluating rilzabrutinib for the treatment of pemphigus, Phase 3 trial of Libtayo (cemiplimab) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer, Dupixent (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients, Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting, New Dupixent (dupilumab) data in patients as young as 6 years old with moderate-to-severe atopic dermatitis to be presented at WCPD and EADV, Sanofi streamlines Consumer Healthcare portfolio in Latin America with divestiture of eight brands to Hypera Pharma, Sanofi announces Paris 2024 Premium partnership for the Olympic and Paralympic Games in Paris, New research presented at IDWeek 2021 reinforces Sanofis robust vaccines pipeline and commitment to advancing public health protection, Sanofi launches dedicated vaccines mRNA Center of Excellence, Sanofi provides update on venglustat clinical program, Dupixent (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis, Sanofi launches 3 million Planet Mobilization fund to support employees environmental projects, Sanofi streamlines Consumer Healthcare portfolio in Europe with divestiture of 16 brands to STADA, Sanofi appoints new leaders to Executive Committee and announces future Chair of EUROAPI, Sanofi to acquire Kadmon to further strengthen growth of transplant business, US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness, New data in blood cancers, hemophilia, and other hematological disorders to be presented at ASH 2021, Conversion of Kiadis to a private limited liability company postponed until completion of statutory buy-out proceedings, Sanofi provides update on avalglucosidase alfa EU submission for patients with Pompe Disease, Online availability of Sanofis half-year financial report for 2021, Sales growth accelerated - Full-year guidance raised, Pivotal data at ATS 2021 show Dupixent (dupilumab) significantly reduced asthma attacks and improved lung function in children, Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate, Sanofi to provide manufacturing support to Johnson & Johnson for their COVID-19 vaccine to help address global supply demands, Sanofi declares the offer for Kiadis unconditional, New indication for Plavix (clopidogrel) now approved in the European Union, Sanofi establishes three-year collaboration with Stanford Medicine to accelerate immunology research, Positive Phase 3 Libtayo (cemiplimab) results in advanced cervical cancer presented at ESMO Virtual Plenary, Delisting of Kiadis will be effective on 25 May 2021, European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma, Interim late-breaking clinical data validate not-alpha profile of THOR-707 (SAR444245), Sanofis novel investigational IL-2, Sanofi presents amended protocols in fitusiran clinical studies at EAHAD 2021, FDA approves Libtayo (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma, CHMP recommends approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma, FDA accepts Dupixent (dupilumab) for review in children with moderate-to-severe asthma, Sanofi to provide support to BioNTech in manufacturing their COVID-19 vaccine to help address public health needs, Sanofis Board of Directors proposes the appointment of Christian Brandts and Barbara Lavernos as Board Members, New data to be featured at EHA 2021 Congress highlight Sanofis ongoing commitment to rare blood disorders, Sanofi continued its growth trajectory. European Commission - Press Release details page - European Commission - Press release Brussels, 14 October 2015 Refugee Crisis: European Commission reports on progress in implementation of priority actions Ahead of the European Council of 15 October, the Commission has today put on the table a Communication describing the State of Play of the implementation of the priority actions European Medicines Agency (EMA) Committee for Orphan Medicinal Products. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Hart-Scott-Rodino waiting period expires for Sanofis acquisition of Principia Biopharma Inc. EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease, Sanofi offers to acquire Kiadis, a clinical-stage company developing cell-based immunotherapy products, CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis, Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies, Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein-based COVID-19 vaccine, New England Journal of Medicine publishes positive final results from Phase 1/2a study of BIVV001 in people with severe hemophilia A, European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma, Sanofi completes Principia Biopharma Inc. acquisition, Dupixent (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in childrens lung function in a randomized Phase 3 trial, Sarclisa (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma, Sanofi offers to acquire Kiadis for 308 million, Late-breaking ESMO presentation shows Libtayo (cemiplimab) monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of 50%, Sanofi invests to make France its world class center of excellence in vaccine research and production, Sanofi Q3 2020 business EPS(1) growth of 8.8% at CER, Dupixent (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma, Dupixent (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings, Sanofi announces closing of Regeneron stock sale, New clinical and health-related quality of life data in multiple myeloma and rare blood disorders to be presented at ASH 2020, Safety and efficacy of Dupixent (dupilumab) in patients as young as 6 years with moderate-to-severe atopic dermatitis further reinforced by new data analyses presented at EADV, Sanofis virtual R&D Day event to highlight capabilities, platforms, and expertise in disease pathways to deliver potentially transformative treatments to patients, Sanofi to present growth opportunities and development strategy for Dupixent (dupilumab) in type 2 inflammatory diseases, CHMP recommends approval of Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older, European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent (alirocumab), Positive pivotal data for Libtayo (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO, Online availability of Sanofis half-year financial report for 2020, Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation, Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate, Sanofi announces positive long-term efficacy and safety data for fitusiran from interim analysis of Phase 2 extension study in people with hemophilia A and B, with or without inhibitors, Availability of the Q3 2020 Memorandum for modelling purposes, Sanofi and Regeneron provide update on Kevzara (sarilumab) Phase 3 U.S. trial in COVID-19 patients, Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine, Nirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trial, Sanofi to present oncology strategy, provide update on portfolio and emerging pipeline, Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas, Sanofi : FDA approves Sarclisa (isatuximab-irfc) for patients with relapsed refractory multiple myeloma, COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries, Sanofi : Filing of the 2019 U.S. Form 20-F and French Document dEnregistrement Universel containing the Annual Financial Report, Sanofi : Availability of the Pre-quarterly Results Communication, Sanofi announces pricing of Regeneron stock offering, Sanofi: FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis, Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine, Sanofi: First patient outside U.S. treated in global Kevzara (sarilumab) clinical trial program for patients with severe COVID-19, Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis, Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19, Sanofi: Annual General Meeting of April 28, 2020, Libtayo (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma, Sanofi's Board of Directors proposes the appointment of Rachel Duan and Lise Kingo as independent directors, Sanofi to highlight pipeline programs in a series of interactive virtual sessions leading to a R&D day event, Sanofi delivers strong 2019 business EPS growth of 6.8% at CER, Sanofi: Phase 3 trial of Libtayo (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival, Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19, Sanofi names new leaders to Executive Committee, Sanofi: Availability of the Pre-quarterly Results Communication, Sanofi brain-penetrant BTK inhibitor significantly reduced disease activity in Phase 2 trial in relapsing multiple sclerosis, Libtayo (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time, FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination, Sanofi successfully prices EUR 1.5 billion of bond issue, Sanofi receives positive CHMP opinion for Sarclisa (isatuximab) for the treatment of relapsed and refractory multiple myeloma, Sanofi : Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency, Sanofi and Regeneron provide update on U.S.
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