The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
Accelererande omsättningstillväxt med fortsatta forskningsframsteg understryker övergången till en långsiktigt hållbar tillväxt
AstraZeneca levererade en stark intäktstillväxt på 23% (18% i fasta valutakurser1) under halvåret till 15 540 MUSD medan intäkterna under andra kvartalet ökade med 31% (25% i fasta valutakurser) till 8 220 MUSD. Exklusive bidraget från COVID-19-pandemivaccinet ökade in
In a large real-world study, data published as a pre-print on The Lancet server from over one million individuals assessed the incidence rates of blood clotting disorders of thromboembolism and thrombocytopenia, including the very rare thrombosis with thrombocytopenia (TTS) following vaccination with an mRNA vaccine or Vaxzevria, and compared them with expected rates in a general population.....
The data, published in The Lancet today, demonstrated the estimated rate of TTS following a second dose of Vaxzevria was 2.3 per million vaccinees, comparable to the background rate observed in an unvaccinated population. It was 8.1 per million vaccinees after the first dose.1 The rate after the second dose is comparable to background rates observed in unvaccinated populations
Alexion’s Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively
AstraZeneca today completed the acquisition of Alexion Pharmaceuticals, Inc. (Alexion). The closing of the acquisition marks the Company’s entry into medicines for rare diseases and the beginning of a new chapter for AstraZeneca.
AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin).
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and 12 to 2 that the benefit-risk profile of roxadustat does not support approval for the treatment of a
The UK Competition and Markets Authority has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion). As a result, the acquisition is expected to close on 21 July 2021.
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.
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A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose.
The results, published by the University of Oxford on the pre-print server of The Lancet, demonstrated that antibody levels remain elevated from baseline for at least one year following
AstraZeneca today appointed Dr. Susan Galbraith to lead Oncology Research & Development from initial discovery through late-stage development.
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
Nirsevimab is being developed as a passive immunisation against RSV for all infants
The MEDLEY Phase II/III trial evaluated the safety and tolerability of nirsevimab compared to Synagis(palivizumab) when given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season.1
The trial assessed the safety of nirsevimab in infants with chronic lung disease (CLD), c
The first participants in a Phase II/III trial for the new COVID-19 variant vaccine AZD2816 were vaccinated today to assess its safety and immunogenicity in both previously vaccinated and unvaccinated adults.