Ämnen: Industri, tillverkning
Lynparza granted Priority Review in the US for BRCA-mutated HER2-negative high-risk early breast cancer
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) has been accepted and granted Priority Review in the US for the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
AstraZeneca unveils The Discovery Centre (DISC) in Cambridge
AstraZeneca will today, in the presence of His Royal Highness The Prince of Wales, formally unveil The Discovery Centre (DISC) in Cambridge, UK – a state-of-the-art research and development (R&D) facility designed to the world’s highest environmental standards and accommodating over 2,200 research scientists.
New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention
New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.
Two billion doses of AstraZeneca’s COVID-19 vaccine supplied to countries across the world less than 12 months after first approval
Approximately two-thirds of these have gone to low- and lower-middle-income countries, including more than 175 million doses delivered to 130 countries through the COVAX Facility.
AstraZeneca PLC:s resultatrapport för de första nio månaderna och tredje kvartalet 2021
AstraZeneca stärker det vetenskapliga ledarskapet under kvartalet tack vare exceptionella framgångar i produktportföljen och tillskottet av Alexion.
AstraZeneca advances ambition to redefine care for blood cancer at ASH 2021
AstraZeneca will present new data underscoring its commitment to transforming haematologic cancer care at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, 11 to 14 December 2021.
AstraZeneca to transfer global rights for Eklira and Duaklir to Covis Pharma
AstraZeneca has agreed to transfer its global rights to Eklira (aclidinium bromide), known as Tudorza in the US, and Duaklir (aclidinium bromide/formoterol) to Covis Pharma Group (Covis Pharma).
Imfinzi plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase III trial at interim analysis
First immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting
Positive high-level results from the TOPAZ-1 Phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemother
Imfinzi plus tremelimumab significantly improved overall survival in HIMALAYA Phase III trial in 1st-line unresectable liver cancer
Positive high-level results from the HIMALAYA Phase III trial showed a single, high priming dose of tremelimumab added to Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC)......
AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial
Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.
Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE).
Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. The FDA grants ODD status to medicines and potential new medicines intended for the treatment
AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US
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 to fully acquire Caelum Biosciences
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.
Saphnelo approved in Japan for systemic lupus erythematosus
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.
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