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  • AstraZeneca
    Karlebyhus, Astraallén 151 85 SÖDERTÄLJE
    08-553 260 00
    08-553 290 00
    http://www.astrazeneca.se
  • Freja Annamatz

    Presschef


    +46722084748
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    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submitted BLA based on TROPION-Lung01 Phase III trial for patients with nonsquamous NSCLC has been voluntarily withdrawn.AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan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

    Alexion, AstraZeneca Rare Disease data at the 2024 AANEM Annual Meeting and MGFA Scientific Session further demonstrate advancement in gMG care

    Clinical and real-world data will reinforce the long-term safety and efficacy profiles of Ultomiris and Soliris and highlight the potential for sustained treatment to minimise steroid use.Alexion, AstraZeneca Rare Disease, will present data from its leading generalised myasthenia gravis (gMG) portfolio at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session taking place in Savannah, GA, 15 to 18 October 2024. The company will present 11 abstracts, spanning clinical and real-

    Rättelse: AstraZeneca i Södertälje utsett till Global Lighthouse av World Economic Forum

    Två av AstraZenecas globala och mest avancerade tillverkningsanläggningar för läkemedel, i Södertälje och i Wuxi, Kina, har idag blivit utsedda till att ingå i World Economic Forum (WEF) Global Lighthouse Network.Rättelse avseende antal anläggningar samt årtal – ny text i kursiv Erkännandet är ett resultat av AstraZenecas satsningar på moderna teknologier, avancerad analys, automation och ny tillverkningsteknik för att driva förbättringar inom industrin. –  Vi är mycket glada att välkomna två av AstraZenecas tillverkningsanläggningar till WEF Global Lighthouse Network. Detta är en av

    AstraZeneca i Södertälje utsett till Global Lighthouse av World Economic Forum

    Två av AstraZenecas globala och mest avancerade tillverkningsanläggningar för läkemedel, i Södertälje och i Wuxi, Kina, har idag blivit utsedda till att ingå i World Economic Forum (WEF) Global Lighthouse Network.Erkännandet är ett resultat av AstraZenecas satsningar på moderna teknologier, avancerad analys, automation och ny tillverkningsteknik för att driva förbättringar inom industrin. –  Vi är mycket glada att välkomna två av AstraZenecas tillverkningsanläggningar till WEF Global Lighthouse Network. Detta är en av de mest prestigefyllda globala utmärkelserna, med endast 21

    AstraZeneca strengthens its cardiovascular pipeline with agreement for a pre-clinical novel lipid-lowering therapy

    AstraZeneca has entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidaemia. This asset further strengthens the company’s cardiovascular portfolio to help address the major risk factors driving chronic cardiovascular disease.   Under the terms of the agreement, AstraZeneca will receive access to CSPC’s pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, with

    Airsupra demonstrated statistically significant and clinically meaningful reduction in risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial

    Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis. AstraZeneca’s inhaled anti-inflammatory rescue medication Airsupra demonstrated significant benefit compared to albuterol. Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed

    Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma

    Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Submission to be reviewed under Project Orbis. AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant

    Enhertu granted Priority Review in the US for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy

    Based on DESTINY-Breast06 Phase III trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for Enhertu. If approved, AstraZeneca and Daiichi Sankyo’s Enhertu will be the first HER2-directed therapy and ADC for patients prior to receiving chemotherapy for metastatic breast cancer. Enhertu also granted Breakthrough Therapy Designation in the US for this patient population. AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority

    Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

    Based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival by more than three years. AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test.

    Fasenra recommended for approval in the EU by CHMP for the treatment of 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 corticosteroids. AstraZeneca’s Fasenra (benralizumab) has been recommended for approval 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 Committee for Medicinal Products for Human Use (CHMP) of the European

    Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

    Survival results for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy. Trial previously met the dual primary endpoint of progression-free survival. High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic

    FluMist approved for self-administration in the US

    Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection. FluMist has been approved in the US as the only self-administered influenza vaccine. FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.[1] The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could

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