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

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    +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 -

    Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD

    Phase III, PINNACLE 4 trial demonstrates positive top-line results compared to its monotherapy components and placebo Trial supports filing of new drug applications in Japan and ChinaAstraZeneca today announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere* (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and

    Bydureon EXSCEL trial demonstrates favourable CV safety profile and fewer CV events in patients with type-2 diabetes at wide range of CV risk

    Largest and most inclusive patient population of any GLP-1 CV outcomes trial with 14,500 patients at 687 trial sites across 35 countries Full trial results presented at the annual meeting of the European Association for the Study of Diabetes (EASD) and simultaneously published in the New England Journal of MedicineAstraZeneca today announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that showed cardiovascular (CV) safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk. Exenatide

    AstraZeneca and Aspen enter agreement for remaining rights to anaesthetic medicines

    Agreement builds on 2016 collaboration on commercialisation rights to anaesthetic medicines in markets outside the USAstraZeneca today announced that it has entered into an agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, under which AGI will now acquire the residual rights to the established anaesthetic medicines comprising of Diprivan, EMLA, Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest. AstraZeneca entered into an agreement 

    Astrazeneca presents new results identifying severe asthma patients who would benefit most from Benralizumab

    Further analysis of the Phase III trials, SIROCCO and CALIMA, reinforces benralizumab’s efficacy and identifies more frequent prior exacerbations and/or greater baseline blood eosinophil count as key predictors of an enhanced treatment effect Findings pave the way for a personalised treatment approach to guide more precise selection of the benralizumab-responsive patient and help achieve maximum clinical benefit11 September 2017 AstraZeneca today announced results from a subgroup analysis of the SIROCCO and CALIMA Phase III trials. The results confirm benralizumab’s compelling

    AstraZeneca presents superior progression-free survival for Imfinzi in the PACIFIC trial of patients with locally-advanced unresectable lung cancer

    Imfinzi improves progression-free survival (PFS) by more than 11 months compared to standard of care and is the first medicine to show superior PFS in this setting Data presented at the ESMO 2017 Congress follows FDA’s recent Breakthrough Therapy Designation for Imfinzi in locally advanced, unresectable lung cancer The PACIFIC trial continues to evaluate the other primary endpoint, overall survivalAstraZeneca and MedImmune, its global biologics research and development arm, have presented the full PFS data from a planned interim analysis of the Phase III PACIFIC trial. Results show

    AstraZeneca's Tagrisso shows potential as a new standard of care in 1st-line EGFR-mutated lung cancer at ESMO 2017 Congress

    Phase III FLAURA trial results show Tagrisso reduced the risk of progression or death by more than half, with consistent benefit across all subgroups, including patients with and without brain metastases Unprecedented median progression-free survival (PFS) of 18.9 months compared with 10.2 months for the current standard of care Clinically-meaningful preliminary overall survival benefitAstraZeneca has presented the full results of the Phase III FLAURA trial, which support Tagrisso’s (osimertinib) clear potential as a new standard of care (SoC) in the 1st-line treatment of adult

    Celgene and AstraZeneca provide update on the FUSION clinical trial programme

    AstraZeneca and MedImmune, its global biologics research and development arm, have been informed by partner Celgene that the US Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION programme. The trials are testing Imfinzi (durvalumab), an anti-PD-L1 agent, in combination with immunomodulatory agents, with or without chemotherapy, in blood cancers such as multiple myeloma, chronic lymphocytic leukaemia and lymphoma. The decision by the FDA was based on risks identified in other trials for an anti-

    Duaklir significantly improves lung function in COPD patients

    Phase III AMPLIFY trial demonstrated a statistically significant improvement in lung function in patients with COPD Study achieved the primary endpoints to support a New Drug Application (NDA) submissionAstraZeneca today announced positive top-line results from the Phase III AMPLIFY trial for Duaklir* (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints, demonstrating a statistically significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component (

    Tezepelumab significantly reduced asthma exacerbations for a broad population of patients with severe uncontrolled asthma

    First-in-class treatment that blocks thymic stromal lymphopoietin (TSLP) – an upstream driver of inflammation in asthma Results published in New England Journal of Medicine Late-breaking abstract at European Respiratory Society International Congress highlights results from the PATHWAY Phase IIb trial of tezepelumab in patients with severe, uncontrolled asthmaAstraZeneca and Amgen Inc. (Amgen) announce results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe,

    AstraZeneca to present data on next generation of biologics at European Respiratory Society International Congress 2017

    Presentation of the PATHWAY Phase IIb data for tezepelumab, a first-in-class treatment that blocks thymic stromal lymphopoietin (TSLP), in patients with severe, uncontrolled asthma New analysis of benralizumab Phase III trials, SIROCCO and CALIMA, which reinforces the potential new medicine’s efficacy and identifies key predictors of an enhanced treatment effectAstraZeneca and its global biologics research and development arm, MedImmune, will present new data on its respiratory portfolio and pipeline at the European Respiratory Society (ERS) International Congress, 9-13 September 2017 in

    AstraZeneca highlights latest advances in lung cancer at the ESMO 2017 Congress

    More than 40 presentations, including data from two pivotal trials selected as late-breaking abstracts for oral presentation in the ESMO Presidential Symposia Phase III PACIFIC data reinforce potential of Imfinzi following US FDA breakthrough therapy designation in locally-advanced (Stage III) unresectable NSCLC Phase III FLAURA results highlight superiority of Tagrisso over standard of care in previously-untreated patients with advanced EGFRm NSCLCAt the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, 8-12 September, AstraZeneca and MedImmune, its global

    AstraZeneca and Takeda establish collaboration to develop and commercialise MEDI1341 for Parkinson’s disease

    AstraZeneca and Takeda Pharmaceutical Company Limited today announced that they have entered an agreement to jointly develop and commercialise MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).  Alpha-synuclein (α-synuclein) is an aggregation-prone protein that contributes to the development of PD. This protein is the major constituent of Lewy bodies, which are pathological protein aggregates that accumulate in the nerve cells of patients with PD and appear to spread throughout the nervous system during the progression of

    Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer

    20% reduction in disease progression vs anastrozole, a current standard treatment option Expanded approval provides earlier benefit for advanced breast cancer patients not previously treated with endocrine therapyAstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. The FDA approval

    Extended treatment with Brilinta reduces risk of cardiovascular death by 29% in patients with history of heart attack

    New sub-analysis to be presented at the European Society of Cardiology (ESC) congress provides additional evidence of cardiovascular (CV) benefits associated with longer-term use of BrilintaAstraZeneca today announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction in CV death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death. Patients received

    Lynparza receives additional and broad approval in the US for ovarian cancer

    Lynparza’s new tablet formulation approved as maintenance treatment for women with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status Lynparza tablets also indicated in BRCA-mutated ovarian cancer beyond the third-line setting Newly-approved tablet formulation means improved patient convenienceAstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the U.S. and Canada) today announced that the US Food and Drug Administration (FDA) has granted approval for the PARP inhibitor, Lynparza (olaparib), as follows: · New use of Lynparza as a

    Registerdata visar: SGLT-2-hämmare, jämfört med andra glukossänkande läkemedel, förknippas med minskad risk för prematur hjärt-kärlsjukdom och död

    Resultat publicerade i The Lancet Diabetes & Endocrinology från observationsstudien CVD-REAL Nordic inkluderar över 90 000 patienter, baserad på registerdata från bland annat Sverige under åren 2012-2015, indikerar att behandling av typ 2-diabetes med SGLT-2-hämmare i klinisk praxis är associerad med minskad risk för kardiovaskulära insjuknanden, särskilt med dödlig utgång, jämfört med andra glukossänkande läkemedel, även hos patienter utan känd hjärt-kärlsjukdom– Detta är mycket intressanta resultat, säger Jan Eriksson, professor i diabetologi vid Uppsala universitet och medlem i den

    US FDA accepts regulatory submission for acalabrutinib and grants priority review

    AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor. The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. This follows the FDA’s recent

    Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma

    AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers. The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that

    Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer

    Fourth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine in three yearsAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at

    Tagrisso significantly improves progression-free survival in the phase III FLAURA trial for lung cancer

    Tagrisso met the primary endpoint, demonstrating a statistically-significant and clinically-meaningful progression-free survival benefit in 1st-line EGFRm non-small cell lung cancer compared to current standard-of-care treatmentAstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor

    AstraZeneca reports initial results from the ongoing MYSTIC trial in stage IV lung cancer

    Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy The MYSTIC trial continues as planned to assess the additional primary endpoints of overall survival for Imfinzi monotherapy and for the Imfinzi plus tremelimumab combinationAstraZeneca and MedImmune, its global biologics research and development arm, today announced progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with

    AstraZeneca and Merck establish strategic oncology collaboration

    Collaboration aims to maximise the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumour types AstraZeneca and Merck will independently develop and commercialise Lynparza and potential medicine selumetinib in combinations with companies’ respective PD-L1/PD-1 immuno-oncology medicines Imfinzi and Keytruda Collaboration will significantly expand the potential of Lynparza, the world’s first and leading PARP inhibitor, as a backbone of combination

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