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Lynparza in combination with abiraterone significantly delayed disease progression in all-comers in PROpel Phase III trial in 1st-line metastatic castration-resistant prostate cancer
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 to discover and develop self-amplifying RNA therapeutics in new collaboration with VaxEquity
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 to invest $360m in advanced manufacturing facility in Ireland
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.
Imfinzi plus chemotherapy tripled patient survival at three years in the CASPIAN Phase III trial in extensive-stage small cell lung cancer
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.
Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer
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
Enhertu demonstrated robust and durable tumour response of 54.9% in patients with HER2-mutant metastatic non-small cell lung cancer
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
Enhertu demonstrated clinically meaningful and durable response in patients with HER2-positive advanced gastric cancer in DESTINY-Gastric02 Phase II trial
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-
Imfinzi combined with novel immunotherapies improved clinical outcomes for patients with unresectable, Stage III non-small cell lung cancer
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
Imfinzi and tremelimumab with chemotherapy improved progression-free survival by 28% and overall survival by 23% in 1st-line Stage IV non-small cell lung cancer vs. chemotherapy
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.
Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits for asthma patients in MANDALA and DENALI Phase III trials
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 European Commission reach settlement agreement over vaccine supply, ending litigation
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 approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
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 lung and breast cancer data at WCLC and ESMO 2021 underscore ambition to revolutionise outcomes for patients
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.
Forxiga approved in Japan for the treatment of chronic kidney disease in patients with and without type-2 diabetes
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
ALXN1840 FoCus Phase III trial in Wilson disease met primary endpoint demonstrating improvement in copper mobilisation from tissues
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.
Update on CHAMPION-ALS Phase III trial of Ultomiris in amyotrophic lateral sclerosis
Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS).
AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
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.
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
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.
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type-2 diabetes
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).
Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer
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).