eu commission press releases

The European Commission has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. On 14 July 2022, the EU Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC), in which the EU Commission proposes to leverage on the technical standards and proven expertise of the . The proposal aims to ensure that instant payments in euro are affordable, secure, and processed without hindrance. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential for BRUKINSA to provide clinical benefit to patients with MZL, the future development, regulatory filing and approval, commercialization . Beneath the rattlesnake are the words: "DONT TREAD ON ME". Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. This site is managed by the European Commission, Directorate-General for Communication, Contact details: institutions, bodies and agencies, EESC backs criticism of investor-State dispute settlement (ISDS), and calls for a more holistic approach, Monthly update of the symmetric adjustment of the equity capital charge for Solvency II end-October 2022, Integration of immigrants in the European Union, Readout of phone call between President von der Leyen and President Zelenskyy, EIB at COP27: MDBs to expand support for countries seeking climate-resilient sustainable transition, DPRK: Statement by the High Representative on behalf of the EU on the recent launch of multiple missiles, Discurso (mensagem gravada) para o XIV Congresso da Ordem dos Revisores Oficiais de Contas, Annual meeting of the EU Innovation Hub: research and innovation making a difference for citizens security, Court of Justice of the European Union (CJEU), European Economic and Social Committee (EESC), European Data Protection Supervisor (EDPS), Publications Office of the European Union. All EDQM press releases. 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. https://clinicaltrials.gov/ct2/show/results/NCT02878330. Healthy preterm infants of 2935 weeks gestation were randomized (2:1) to receive a single 50mg intramuscular injection of Beyfortus or placebo. Latest press releases. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Embargoed 15:00 CET Wednesday 2 November. Senhores convidados para este Congresso Presentation at the European Migration Forum - 7th meeting "Youth inclusion: key to successful migrant integration" on 20-21 October 2022. The AG recommended to overturn the judgment that annulled the EC's decision blocking the intended acquisition of Telefnica UK (O2) by CK Hutchison in the UK in 2015. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. 2020;146:e20193611. Risk of primary infection and reinfection with respiratory syncytial virus. The European Commission has published the first European Aviation Environmental Report, the result of close collaboration between the EC, the European Aviation Safety Agency (EASA), the European Environment Agency (EEA) and EUROCONTROL.The main objective is to provide a regular overview of the environmental . Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. . 2002;21(7):629-32. 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.

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