The safety and efficacy of Beyfortus was evaluated under an accelerated assessment procedure by the EMA. It is a recombinant adeno-associated virus serotype 2 (AAV2)-based gene therapy, containing the human DDC gene. Beyfortus has been granted marketing authorization in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants from birth during their first RSV season. Glezen WP et al. Accessed October 2022. 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Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against the disease.20. Offer Memorandum for All Outstanding Shares of Kiadis Pharma N.V. Sanofi launches recommended cash offer for all shares in Kiadis, The Lancet publishes Libtayo (cemiplimab) data showing extended overall survival in patients with first-line advanced non-small cell lung cancer with PD-L1 expression of 50%, FDA approves Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma, Phase 3 trial of Libtayo (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival, Kiadis shareholders give irrevocable commitment to tender 36.6% of the shares under the offer by Sanofi, New Dupixent (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years, Sanofi and Kiadis satisfy competition condition related to the tender offer, Sanofi pioneers sustainable finance in the pharmaceutical industry with the signing of its two first sustainability-linked revolving credit facilities, Update on the intended offer by Sanofi for Kiadis, CHMP recommends approval of Plavix (clopidogrel) with aspirin in adults for certain types of strokes, Dupixent (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis, Sanofi renews partnership with the WHO to fight Neglected Tropical Diseases and eliminate sleeping sickness before 2030, FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease. The approval was based on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.3-11 In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose.3-8 The safety profile of Beyfortus was similar to placebo. ESPID 2022 Congress; 2022 May 9-13. EU commits 7.2 million to step up Ebola fight in DR Congo. European Commission grants first approval worldwide of Beyfortus (nirsevimab)for prevention of RSV disease in infants. Viral and host factors in human respiratory syncytial virus pathogenesis. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. J Infect Dis. The EU issued a statement on the recent launch of multiple missiles by the Democratic Peoples Republic of Korea. The Commission has adopted a legislative proposal to make instant payments in euro available to all citizens and businesses holding a bank account in the EU and in EEA countries. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. The European Commission has allocated 7.2 million to strengthen its response to an outbreak of Ebola in the Democratic Republic of Congo, bringing the total amount of EU aid to the combat the deadly virus at 12.83 million in 2018. The primary endpoint was met, reducing the incidence of medically attended LRTI, caused by RSV by 70.1% (95% CI: 52.3, 81.2) compared to placebo. https://clinicaltrials.gov/ct2/show/NCT03979313. Synagis - Summary of Product Characteristics (SmPC) - (eMC) [Internet]. Accessed October 2022. 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. The verdict is in from an analysis of 45,000 press releases: The Commission keeps it complicated even compared to other governments. The winners of the European PRRS Award 2022 October 10, 2022 Bridging science and veterinary practice for swine health: The winners of the European PRRS . ESPID 2022 Congress; 2022 May 9-13. Athens, 04.11.2022 - Address by President of the Swiss Confederation and Head of the Federal Department of Foreign Affairs FDFA, Ignazio Cassis - check against delivery. Latest press releases and statements. The European Insurance and Occupational Pensions Authority (EIOPA) has published the technical information on the symmetric adjustment of the equity capital charge for Solvency II with reference to the end of October 2022. Pediatrics. Lancet 2022;399:9204764. NEJM 2020; 383: 415-425. https://clinicaltrials.gov/ct2/show/NCT03979313. Today the Commission is proposing stronger rules on ambient air, surface and groundwater pollutants, and treatment of urban wastewater.Clean air and water are essential for the health of people and ecosystems. The proposal aims to ensure that instant payments in euro are affordable, secure, and processed without hindrance. https://clinicaltrials.gov/ct2/show/results/NCT02878330. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. Risk of primary infection and reinfection with respiratory syncytial virus. ESPID 2022 Congress; 2022 May 9-13. Accessed October 2022. Press releases Daily News 31 / 10 / 2022 31 October 2022 Press release 16 September 2021 Philadelphia:943-9. Wilkins, D, et al. Prime Minister Rishi Sunak spoke to European Commission President Ursula Von Der Leyen at COP27 in Egypt today. Email The Phase 3 MELODY trial was a randomized, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI due to RSV confirmed by reverse transcriptase polymerase chain reaction testing through 150 days after dosing, versus placebo, in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season.3,4The primary endpoint was met, reducing the incidence of medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. Between July 2019 and March 2020, 1,490 infants were randomized to either Beyfortus or placebo at the RSV season start.3,4Data was published on the primary analysisinNEJMin March 2022. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. BRUSSELS - The European Commission, in a reply to a question put by ruling New Democracy MEP Manolis Kefalogiannis, said that Turkey must respect the sovereignty, territorial integrity and sovereign rights of all EU member-states or face repercussions, according to a press release issued by the MEP 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 . At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV., The European Commission is the first regulatory body to grant approval to Beyfortus. RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two.1,2 Beyfortus is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Accessed October 2022. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) through 360 days post-dose.9,10 Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in the healthy term and late preterm infants is likely.9 Data was published in NEJM in March 2022. 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. Once launched, Beyfortus will offer parents the ability to help protect their babies during their first RSV season., Iskra ReicVaccines and Immune Therapies Unit, AstraZeneca Beyfortus is the first single-dose passive immunization against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population. (2020). European Medicines Agency. Highlights, press releases and speeches. The WMO's State of the Climate in Europe report, produced jointly with the European Union's Copernicus Climate Change Service, focused on 2021, provides information on rising temperatures, land and marine heatwaves, extreme weather, changing precipitation patterns and retreating ice and snow.
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