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  • AstraZeneca
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    http://www.astrazeneca.se
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    Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn

    AstraZeneca and Daiichi Sankyo have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01  Phase III trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). AstraZeneca and Daiichi Sankyo will continue to work to bring datopotamab

    Tagrisso approved in the EU for patients with unresectable EGFR-mutated lung cancer

    First and only EGFR inhibitor and targeted treatment approved in the EU in unresectable NSCLC. Approval based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years.AstraZeneca’s Tagrisso (osimertinib) has been approved in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following

    Non-Executive Board Appointments

    AstraZeneca PLC announced today that Rene Haas and Birgit Conix have been appointed as Non-Executive Directors with effect from 1 January 2025 and 1 February 2025 respectively. Birgit will become a member of the Audit Committee on appointment to the Board. Rene is Chief Executive Officer of Arm.  Birgit is Chief Financial Officer of Sonova.  Further biographical details are set out below. Michel Demaré, Chair of AstraZeneca, said “I am confident Rene and Birgit will be excellent additions to the AstraZeneca Board.  We look forward to welcoming them as we continue the process of

    Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase III trial

    87.5% of patients treated with Lynparza were alive at six years vs. 83.2% in the comparator arm. First and only PARP inhibitor to improve overall survival in early breast cancer.Updated results from the OlympiA Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. These results were presented today at the San

    Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

    First Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan. Based on TROPION-Lung05 Phase II trial and supported by data from TROPION-Lung01 Phase III trial.Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.  The US Food and

    Fixed-duration Calquence plus venetoclax demonstrated superior PFS vs. standard of care in previously untreated CLL, with 77% of patients progression free at three years in AMPLIFY Phase III trial

    Calquence plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 58% versus standard of care in this setting. Calquence plus venetoclax poised to become first all-oral fixed-duration regimen of a second-generation BTK inhibitor plus venetoclax in 1st-line CLL.Positive results from the AMPLIFY Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously

    Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer

    Decision based on NIAGARA Phase III trial results which demonstrated a statistically significant and clinically meaningful event-free and overall survival benefit. If approved, this will be the first and only perioperative immunotherapy regimen in this curative-intent setting.AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC).   The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that,

    Imfinzi approved in the US as first and only immunotherapy regimen for patients with limited-stage small cell lung cancer

    Based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo.AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review 

    AstraZeneca appoints Iskra Reic as Executive Vice President, International

    AstraZeneca today announced the appointment of Iskra Reic as Executive Vice President (EVP), International with responsibility for overall strategy and driving sustainable growth across this broad region. This encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Having joined the Company in 2001, Iskra has held leadership positions across Central & Eastern Europe, Eurasia, Middle East & Africa. She was appointed EVP for Europe & Canada in 2017 and joined AstraZeneca’s Senior Executive Team. Most recently, Iskra launched the Company’

    Truqap improved rPFS in advanced prostate cancer

    First and only AKT inhibitor combination to demonstrate benefit in this specific subtype of prostate cancer.Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). Overall

    Tagrisso recommended for approval in the EU by CHMP for patients with unresectable EGFR-mutated lung cancer

    Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years.AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT). The Committee for

    AstraZeneca invests $3.5 billion in R&D and manufacturing in the United States

    AstraZeneca today announces $3.5 billion of capital investment in the United States focused on expanding the Company’s research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy. AstraZeneca’s expanding footprint in the US includes, among others: · A state-of-the-art R&D centre in Kendall Square, Cambridge, Massachusetts · A next generation manufacturing facility for biologics in Maryland · Cell therapy manufacturing capacity on the West

    Koselugo showed statistically significant and clinically meaningful objective response rate vs. placebo in adults with neurofibromatosis type 1 in global KOMET Phase III trial

    Results demonstrated reduction in tumour volume, building on established safety and efficacy profile of Koselugo in children and supporting expanded use in adults.Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), showed that Koselugo (selumetinib), an oral, selective MEK inhibitor, met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR)

    Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

    AstraZeneca and Daiichi Sankyo’s new application is based on the TROPION-Lung05 Phase II trial and supported by data from additional trials including TROPION-Lung01. Previously submitted BLA based on TROPION-Lung01 Phase III trial for patients with nonsquamous NSCLC has been voluntarily withdrawn.AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) non-small cell

    Resultatrapport för årets första nio månader samt tredje kvartalet 2024

    En uppgradering av prognosen för helåret 2024 underbyggs av ett starkt underliggande tillväxtmomentum   Intäkter och vinst per aktie – sammanfattning     9M 2024 Förändring % Q3 2024 Förändring %[]    MUSD  Utfall  i fasta MUSD  Utfall  i fasta val val uta uta kur kur ser[[1]] ser[]- Produktförsäljning   37 576  16  19  12 947  18  20 - Alliansintäkter   1 498  49

    Tezspire met both co-primary endpoints in the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps

    Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and reduced nasal congestion compared to placebo.Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s Tezspire (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. WAYPOINT is a randomised, double-blind trial that evaluated the efficacy and

    AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024

    First results from AMPLIFY trial will reinforce Calquence as leading second-generation BTK inhibitor in frontline chronic lymphocytic leukaemia with fixed-duration regimen. Next generation cell therapy and T-cell engagers will demonstrate promising early results in multiple types of blood cancer. New, long-term data for Voydeya as add-on to Ultomiris or Soliris will show low rate of breakthrough haemolysis events and sustained improvements in quality-of-life measures in PNH with extravascular haemolysis.AstraZeneca advances its ambition to redefine cancer care with new data across its

    AZN share price movement

    As a matter of policy, we do not comment on speculative media reports including those related to ongoing investigations in China. If requested, we will fully cooperate with the Chinese authorities. We continue to deliver our life changing medicines to patients in China and our operations are ongoing. AstraZeneca  AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including

    AstraZeneca China President currently under investigation

    Leon Wang, Executive Vice President International and AstraZeneca China President, is cooperating with an ongoing investigation by Chinese authorities. Our China operations continue under the leadership of the current General Manager of AstraZeneca China. If requested, AstraZeneca will fully cooperate with the investigation. AstraZenecaAstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including

    Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis

    New indication supported by the MANDARA trial, which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroid.AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.[1,2] The approval by the European Commission follows the positive opinion 

    Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis

    Recommendation based on NEURO-TTRansform Phase III results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy impairment and quality of life versus placebo.AstraZeneca and Ionis’ Wainzua (eplontersen) has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN.[1] If approved by the European Commission, Wainzua will be the only

    AstraZeneca advances science of infectious disease protection at IDWeek 2024

    Data demonstrate the importance of protecting against serious respiratory infections caused by respiratory syncytial virus, human metapneumovirus and COVID-19.AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 13[th] annual IDWeek in Los Angeles, California, from 16-19 October 2024. The Company will highlight progress in advancing novel immunisations against infectious diseases of high unmet need and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection. Iskra Reic, Executive Vice President

    Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic non-small cell lung cancer

    Approval based on DESTINY-Lung02 and DESTINY-Lung05 results which showed Enhertu demonstrated clinically meaningful efficacy in previously treated patients. Fourth approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu across three different tumour types.AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior

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