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

    Extern kommunikationsdirektör


    +46 8 - 553 26020
    +46 72 560 21 57
    http://www.astrazeneca.se
  • Lotta Sjösten

    Presskontakt


    + 46 8 553 271 10
    + 46 72 739 60 52
    http://www.astrazeneca.se
  • Petra Eurenius

    Director Corporate Communication - Nordic Marketing Company


    +46 8 552 51396
    +46 70 918 65 62
    http://www.astrazeneca.se
    • Välj datumintervall -

    US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer

    1st-line use of Tagrisso offers potential new standard of care Tagrisso delivered unprecedented median progression-free survival of 18.9 months versus 10.2 months compared with current standard of careAstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The approval is based on results from

    Updated overall survival data for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer presented at AACR

    AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial showing the final overall survival (OS) results for Lynparza (olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, US, 14-18 April 2018. The trial compared Lynparza with chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine) for patients with germline BRCA-mutated (gBRCAm) HER2-negative metastatic breast cancer and met its primary endpoint of

    1st-line Tagrisso demonstrates sustained benefit post progression in patients with EGFR-mutated non-small cell lung cancer

    Unprecedented progression-free survival benefit for 1st-line Tagrisso demonstrated in the FLAURA trial is preserved through subsequent lines of therapyAstraZeneca today presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA  trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients

    AstraZeneca’s early and late-stage oncology portfolio showcased at AACR annual meeting and ELCC

    New post-progression and quality of life data highlight Tagrisso and Imfinzi benefits in non-small cell lung cancer patients with high unmet need Breadth and depth of DNA Damage Response portfolio reinforced, including overall survival data for Lynparza in metastatic breast cancer Data for Tumour Drivers & Resistance and Immuno-Oncology agents demonstrate strength of next-generation pipelineAstraZeneca and MedImmune, its global biologics research and development arm, will present updates from their early and late stage oncology pipelines at two major congresses this month. In total,

    The European Medicines Agency accepts regulatory submission for Lynparza in BRCA-mutated, HER2-negative metastatic breast cancer

    If approved, AstraZeneca and MSD’s Lynparza would be the first PARP inhibitor to treat patients with breast cancer in EuropeAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the European Medicines Agency has validated for review the Marketing Authorisation Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the

    US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia

    Moxetumomab pasudotox BLA granted Priority ReviewAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set

    Lokelma approved in the EU for the treatment of adults with hyperkalaemia

    Patients will benefit from Lokelma’s rapid reduction and sustained control of potassium levels in the blood4,5AstraZeneca today announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.1,2,3,4 Lokelma is a highly-selective, oral potassium-removing agent. The approval is supported by data from three double-blind,

    Michelle Werner ny marknadsbolagschef för AstraZeneca Nordic-Baltic

    Michelle Werner har tillträtt som chef för AstraZenecas nordisk-baltiska marknadsbolag. Hon kommer närmast från en tjänst som chef för AstraZenecas verksamhet inom cancer i USA. Michelle har arbetat på AstraZeneca i snart tre år, och på ett antal andra läkemedelsföretag under totalt 20 år, bland annat i Frankrike och Storbritannien. ”Jag är verkligen glad över att ha fått möjligheten att leda det Nordisk-Baltiska marknadsbolaget, och att arbeta i Sverige där AstraZeneca har en lång historik och stor närvaro”, säger Michelle Werner. ”I Norden och Baltikum bedrivs världsledande forskning

    AstraZeneca provides update on MYSTIC trial timeline

    AstraZeneca and MedImmune, its global biologics research and development arm, today announced an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab) as monotherapy and in combination with tremelimumab, versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC). MYSTIC is an event-driven clinical trial and continues per protocol. Based on current predictions, the final analysis of overall survival (OS) is now expected in the second half of 2018 (

    New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SGLT-2 inhibitors

    Real-world evidence study of more than 400,000 patients with type-2 diabetes, 74% of whom did not have a history of established cardiovascular disease, supports the association of CV benefits with use of  Latest analysis includes heart attack and stroke endpoints, longer follow-up period and six additional countries across Asia Pacific, the Middle East and North AmericaAstraZeneca today announced results from a new analysis of its landmark CVD-REAL study, the first large real-world evidence study of its kind evaluating the risk of all-cause death (ACD), hospitalisation for heart failure (

    The European Medicines Agency accepts regulatory submission for Forxiga in adults with type-1 diabetes

    First European filing acceptance of a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor in type-1 diabetes AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) clinical programme for Forxiga in T1D. The short-term (24 week)

    AstraZeneca aims to advance clinical practice in CV risk management with new data at ACC 2018

    At the American College of Cardiology (ACC) 67th Annual Scientific Session & Expo 2018, AstraZeneca will deliver industry-leading science and insights that augment the body of evidence on clinical approaches to tackling cardiovascular diseases. The Company will present 10 abstracts, three of which are accepted as ACC late breakers, including: New real-world evidence Findings from the CVD-REAL 2 study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT2 Inhibitors) build upon the landmark CVD-REAL study results that were presented at ACC 2017. CVD-REAL is the

    MedImmune to create stand-alone company for early-stage inflammation and autoimmunity biologics

    AstraZeneca today announced that its global biologics research and development arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programmes into an independent biotech company, Viela Bio. The new company will focus on developing medicines for severe autoimmune diseases by targeting the underlying causes of each disease.    MedImmune will contribute three clinical and three pre-clinical potential new medicines. This includes inebilizumab, currently in Phase II trial development for the treatment of neuromyelitis optica, a rare condition that

    Lynparza receives positive EU CHMP opinion in platinum-sensitive relapsed ovarian cancer

    AstraZeneca and MSD’s new Lynparza tablet formulation recommended for maintenance therapy regardless of BRCA status AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal

    US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer

    Imfinzi is the only immunotherapy approved for patients with unresectable Stage III non-small cell lung cancer Imfinzi showed an 11.2 month improvement in median progression-free survival (16.8 months compared to 5.6 months on placebo)AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (

    Selumetinib granted Orphan Drug Designation by the US FDA for neurofibromatosis type 1

    AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1). NF1 is an incurable genetic condition that affects one in 3,000 births,[i]  with highly-variable symptoms, including cutaneous (skin), neurological (

    Brilinta significantly reduces CV events and coronary death beyond one year in heart attack survivors with multi-vessel disease

    Study reveals prolonging treatment with Brilinta 60mg after one year, reduces risk of major adverse cardiac events (MACE) by 19% and coronary death by 36%1 Builds on analysis2 showing 5-year ischaemic risk post-heart attack and benefits of long-term cardiovascular (CV) protection with Brilinta 60mgAstraZeneca today announced results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial, demonstrating a risk reduction of 19% in MACE (the composite of CV death, myocardial infarction, or stroke) (HR 0.81; 95% CI, 0.7–0.95) and of 36% in coronary death (HR 0.64; 95% CI, 0.45–0.89)

    AstraZeneca PLC:s resultatrapport för helåret och fjärde kvartalet 2017

    Positiv utveckling avseende kommersiellt genomförande och kostnadsdisciplin; produktförsäljningen ökade under kvartalet.AstraZeneca står inför tillväxt i produktförsäljningen för helåret 2018Ekonomisk sammanfattning +-------------------+------+------+---------------+-----+------+------------+| | Helår | Q4 || | 2017 | 2017 |+-------------------+------+------+---------------+-----+------+------------+| | | Förändring | |

    AstraZeneca reports top-line phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease

    PT010 demonstrates significant improvement in six out of seven lung function primary endpoints compared with dual combination therapiesAstraZeneca today announced top-line results from the Phase III KRONOS trial that showed PT010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6µg, using Aerosphere Delivery Technology, in a pressurised metered-dose inhaler or pMDI) demonstrated a statistically significant improvement compared with dual combination therapies in six out of seven lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in

    AstraZeneca listed as one of the world's Top-100 most sustainable companies and recognised for its three-fold increase in renewable energy usage

    AstraZeneca ranked 34th in Corporate Knights’ 14th annual Global 100 list of the most sustainable companies in the world AstraZeneca identified as “biggest achiever” alongside Bank of America, and Coca Cola Enterprises Inc. (now Coca Cola European Partners) for 300% increase in renewable electricity in a single yearAstraZeneca has been recognised for its commitment to sustainability with two new, global accolades: the company has been listed as one of the 100 most sustainable companies in the world by Corporate Knights, the Toronto-based media and investment advisory firm, and has been

    Lynparza receives approval in Japan for the treatment of advanced ovarian cancer

    Lynparza is the first PARP inhibitor approved in Japan Lynparza tablets approved as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer regardless of BRCA mutation statusAstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last

    Fasenra receives approval in Japan

    Approval based on Phase III WINDWARD programme that demonstrated significantreductions in asthma exacerbations, improvements in lung function and reductions inoral corticosteroid use from baseline, versus placebo Fasenra is the first approved respiratory biologic with an 8-week maintenance dosing scheduleAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma

    Lynparza approved by US FDA in germline BRCA-mutated  metastatic breast cancer

    Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer Lynparza reduced the risk of disease progression or death by 42% compared to standard of care chemotherapy AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been

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