AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
AstraZeneca will advance and accelerate ongoing Phase III clinical development of CAEL-101, a potential first-in-class medicine for AL amyloidosis
AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis.
AL amylo
AstraZeneca’s Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment.
Positive high-level results from the PROpel Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus standard-of-care abiraterone as a 1st-line treatment for men with metastatic castration-resistant prostate cancer......
AstraZeneca has reached an agreement to collaborate with VaxEquity for the discovery, development and commercialisastion of the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London.
AstraZeneca is planning on establishing a next-generation active pharmaceutical ingredient (API) manufacturing facility for small molecules near Dublin, Ireland to ensure the Company’s global supply network is fit for future growth.
Updated results from the CASPIAN Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit at three years for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.
Ground-breaking Phase III head-to-head DESTINY-Breast03 results featured at ESMO Presidential Symposium support Enhertu as the potential new standard of care in previously treated patients
DESTINY-Breast01 Phase II trial data also presented at ESMO showed impressive median overall survival of 29.1 months in HER2-positive patients
Detailed positive results from the head-to-head DESTINY-Breas
First HER2-directed therapy to show a strong tumour response in this population Data from HER2-mutant cohort of pivotal DESTINY-Lung01 Phase II trial presented at ESMO and published in The New England Journal of Medicine
First Enhertu trial in Western patients with gastric cancer
Efficacy and safety results consistent with registrational DESTINY-Gastric01 will support ongoing discussions with global health authorities
Detailed results from the positive Phase II DESTINY-Gastric02 trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-dire
COAST Phase II trial showed oleclumab or monalizumab in combination with Imfinzi significantly delayed disease progression and increased objective response rate First effectiveness data from PACIFIC-R reinforced long-term benefit of Imfinzi in the real-world setting
Positive results from the POSEIDON Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, when added to platinum-based chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival compared to chemotherapy alone in the 1st-line treatment of patients with Stage IV non-small cell lung cancer.
Positive high-level results from the MANDALA and DENALI Phase III trials of PT027 (albuterol/budesonide), at both 180/160mcg and 180/80mcg doses, met all primary endpoints demonstrating statistically significant benefits in patients with asthma versus individual components albuterol, also known as salbutamol (180mcg) and budesonide (160mcg).
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]).
Ultomiris (ravulizumab) has been approved in the European Union for expanded use to include children (with a body weight of 10 kg or above) and adolescents with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare and severe blood disorder characterised by the destruction of red blood cells that can cause thrombosis (blood clots) and result in organ damage and potentially premature death. 1-4
AstraZeneca will present new data across its diverse portfolio of cancer medicines at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) Congress 2021.
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial.1
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.
Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS).
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint.