AstraZeneca PLC:s resultatrapport för det fjärde kvartalet och helåret 2020
AstraZeneca levererade ett starkt resultat 2020 i linje med den under året oförändrade prognosen.
Ämnen: Industri, tillverkning
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AstraZeneca and IDT Biologika sign letter of intent to increase COVID-19 vaccine manufacturing in Europe and secure long-term supply capacity
Following the European Medicines Agency (EMA) approval, millions of AstraZeneca vaccines began shipping on 5 February as part of the initial 17m doses that are due to be delivered over the next weeks, with more planned in March.
AstraZeneca and IDT Biologika are exploring options to accelerate output of finished COVID-19 Vaccine AstraZeneca in the second quarter of 2021 in order to help support -
Divestment of Crestor in Europe to Grünenthal completed
AstraZeneca has completed the divestment of the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe to Grünenthal GmbH (Grünenthal). Rights in the UK and Spain were not included in the agreement.
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Update on KESTREL Phase III trial of Imfinzi with or without tremelimumab in the 1st-line treatment of recurrent or metastatic head and neck cancer
The KESTREL Phase III trial for AstraZeneca’s Imfinzi (durvalumab) did not meet the primary endpoint of improving overall survival (OS) versus the EXTREME treatment regimen (chemotherapy plus cetuximab), a standard of care, in the 1st-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumours expressed high levels of PD-L1.
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Forxiga approved in China for heart failure
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF).
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COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials
The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed COVID-19 Vaccine AstraZeneca is safe and effective at preventing COVID-19, with no severe cases and no hospitalisations, more than 22 days after the first dose.
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AstraZeneca agrees to divest Viela shareholding
AstraZeneca has agreed, subject to certain limited exceptions, to divest its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc (Nasdaq: HZNP).
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COVID-19 Vaccine AstraZeneca authorised for use in the EU
AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
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COVID-19 Vaccine AstraZeneca recommended for use in the EU
AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
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Tagrisso extended disease-free survival regardless of prior adjuvant chemotherapy in early-stage EGFR-mutated lung cancer
Results from an exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) extended disease-free survival (DFS) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) regardless of prior adjuvant chemotherapy treatment or stage of disease...
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Datopotamab deruxtecan and Enhertu show promising early clinical activity in patients with advanced non-small cell lung cancer
New data from AstraZeneca and Daiichi Sankyo Company, Limited's datopotamab deruxtecan and Enhertu showed encouraging results from both antibody drug conjugates (ADCs) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The data were presented today in two oral presentations during the World Conference on Lung Cancer (WCLC).
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Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma
AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older.
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Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia
AstraZeneca’s Calquence (acalabrutinib), a next-generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]).
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Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in chronic lymphocytic leukaemia
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukaemia (CLL) compared to ibrutinib.
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Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.
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Enhertu approved in the US for the treatment of patients with previously treated HER2-positive advanced gastric cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
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Imfinzi approved in the EU for less-frequent, fixed- dose use in unresectable non-small cell lung cancer
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
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AstraZeneca to showcase transformative data across diverse pipeline at World Conference on Lung Cancer
Eleven AstraZeneca medicines and potential new medicines from the pipeline feature in 39 abstracts showcasing the Company’s leadership across different types and stages of lung cancer, including eight oral presentations with two late breakers.
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Serum Institute of India obtains emergency use authorisation in India for AstraZeneca’s COVID-19 vaccine
AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults.
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Farxiga granted Priority Review in the US for the treatment of patients with chronic kidney disease
AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
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