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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 -

    AstraZeneca delivers new data on expanding portfolio of cancer medicines at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting

    Lynparza’s potential in BRCA-mutated metastatic breast cancer to be highlighted in plenary presentation of Phase III OlympiAD trial Key trials show further evidence of Tagrisso efficacy in patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases (AURA3 trial) or leptomeningeal disease (BLOOM trial) New data demonstrate advances in Immuno-Oncology, including Imfinzi in non-small cell lung and bladder cancerAstraZeneca, along with its global biologics research and development arm, MedImmune, will demonstrate how it is

    Bydureon EXSCEL trial meets primary safety objective in type-2 diabetes patients at wide range of cardiovascular risk

    Based on a composite measure of major adverse CV events (MACE), Bydureon did not increase cardiovascular (CV) risk and showed a consistent safety profile Fewer CV events were observed in the Bydureon arm, however, the efficacy objective of reduction in CV risk did not reach statistical significanceAstraZeneca today announced top-line results from the Phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial. The trial compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo, when added to usual type-2 diabetes care, on the risk of MACE,

    Phase III Zonda trial for benralizumab shows ability to reduce oral steroid use in severe asthma patients

    Patients treated with benralizumab were more than four times as likely to reduce oral corticosteroid (OCS) dose than those on placebo Benralizumab also reduced overall exacerbation rates by 70% and exacerbations requiring emergency room visits or hospitalisations by 93% in patients with severe, uncontrolled eosinophilic asthma Trial results published simultaneously in New England Journal of MedicineResults from the Phase III ZONDA trial 

    AstraZeneca enters agreement with Recordati for Seloken in Europe

    Agreement expands the commercial potential of Seloken in European markets AstraZeneca to receive upfront payment, plus ongoing income for established heart medicinesAstraZeneca announced today that it has entered into an agreement with Recordati S.p.A (Recordati) for the commercial rights to Seloken/Seloken ZOK (metoprolol tartrate and metoprolol succinate respectively) and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) treatments in Europe. Metoprolol succinate is a beta-blocker for the control of hypertension, angina and heart failure. Recordati will

    Brodalumab receives positive CHMP opinion for the treatment of adult patients with moderate-to-severe plaque psoriasis

    AstraZeneca today announced that its partner LEO Pharma has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of brodalumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Brodalumab is the first and only fully human monoclonal antibody that selectively targets the IL-17 receptor. By binding to the receptor, brodalumab effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are

    AstraZeneca to present scientific advancements from growing respiratory portfolio at the American Thoracic Society conference 2017

    Phase III ZONDA trial shows the potential of benralizumab to reduce or discontinue the use of oral corticosteroidsAstraZeneca and its global biologics research and development arm, MedImmune, will present new data from its growing respiratory portfolio and pipeline at the 113th annual conference of the American Thoracic Society (ATS) in Washington, DC, USA, 19-24 May 2017. The breadth and depth of science behind AstraZeneca’s growing respiratory portfolio and pipeline are reflected in the 59 accepted abstracts, including three oral presentations and 13 poster discussions, which will

    Imfinzi significantly reduces the risk of disease worsening or death in the phase III pacific trial for stage III unresectable lung cancer

    Imfinzi met a primary endpoint of statistically-significant and clinically-meaningful progression-free survival (PFS) in ‘all-comer’ patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer in a planned interim analysis Imfinzi is the first immuno-oncology medicine to show superior PFS in this setting Plans for regulatory submission under active discussion with authoritiesAstraZeneca and MedImmune, its global biologics research and development arm, today announced positive results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-

    AstraZeneca provides update on STRATOS 1 phase III trial of tralokinumab in severe, uncontrolled asthma

    Tralokinumab did not meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate Second pivotal Phase III trial STRATOS 2 is ongoing with results expected in second half of 2017AstraZeneca and MedImmune, its global biologics research and development arm, today announced that tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, did not meet its primary endpoint of a significant reduction in the annual asthma exacerbation rate (AAER) in the overall population of severe, uncontrolled asthma patients, compared with placebo in STRATOS 1, the

    AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer

    Approval granted regardless of PD-L1 status, based on tumour response rate and duration of response Imfinzi is the cornerstone in an extensive Immuno-Oncology programme across multiple cancer types and stages of diseaseAstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-

    AstraZeneca PLC:s resultatrapport för första kvartalet 2017

    En positiv start med fortsatt nyhetsflöde kring vår forskningsportfölj i det som har potential att bli ett avgörande år för bolaget  Ekonomisk sammanfattning  +-------------------+---------+---------+-----------------------+| |MUSD  | Förändring i %  |+-------------------+---------+---------+-----------------------+| | |Utfall[1]|i fasta valutakurser[2]|+-------------------+---------+---------+-----------------------+|Totala intäkter  | 5 405 | (12)  | (10)  |+-------------------+---------

    Tagrisso receives full approval in the EU

    Full approval follows Tagrisso’s expedited Conditional Marketing Authorisation as first-in-class medicine for patients with locally-advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer Tagrisso is a potential new standard of care in 2nd line and subsequent therapy in this hard-to-treat form of lung cancer Approval is based on Phase III AURA3 data which demonstrate significant clinical superiority of Tagrisso over chemotherapy in EGFR T790M mutation-positive NSCLC patients, including those with CNS metastasesAstraZeneca today announced that the European

    Tagrisso (osimertinib) receives US FDA full approval

    Conversion from accelerated to full approval confirms the potential of Tagrisso to become standard of care in the US Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso as compared to chemotherapyAstraZeneca today announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-

    AstraZeneca’s potential medicine for Neuromyelitis Optica Spectrum Disorder receives orphan designation in Europe

    AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Developed by MedImmune, inebilizumab is currently in Phase IIb clinical development for NMOSD. NMOSD is a rare, life-threatening autoimmune disease of the central nervous system in which the body’s immune system attacks healthy cells, most commonly in the optic nerves and spinal cord, resulting in severe damage. NMOSD may

    AstraZeneca to share its robust early science in Oncology with the medical community at AACR 2017

    60 abstracts from early oncology portfolio including 7 oral presentations, across Tumour Drivers and Resistance, Immuno-Oncology, Antibody-Drug Conjugates and DNA Damage Response Potential new medicines targeting cancer cell-death mechanisms highlight potential of emerging Tumour Drivers and Resistance researchAstraZeneca, along with its global biologics research and development arm, MedImmune, will present the strength and depth of its translational science, which is expected to deliver the Company’s next wave of innovative oncology medicines, at the American Association for Cancer

    Tagrisso approved in China as first-in-class treatment for EGFR T790M mutation-positive metastatic non-small cell lung cancer

    First AstraZeneca medicine approved under China’s new Priority Review pathway Tagrisso is an important new medicine in a country where lung cancer is the leading cause of cancer-related deaths and EGFR-mutation rates are among highest globallyAstraZeneca today announced that the China Food and Drug Administration (CFDA) has granted marketing authorisation for Tagrisso (osimertinib) 40 mg and 80mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)

    AZ’s CVD-real study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicines

    Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced all- cause mortality by 51% and risk of hospitalisation for heart failure by 39%   CVD-REAL data are presented at the American College of Cardiology 66th Annual Scientific SessionAstraZeneca today announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalisation for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of

    AstraZeneca and Circassia enter strategic collaboration in respiratory disease

    Circassia will lead promotion of Tudorza and prepare for potential launch of Duaklir in the US Strategic collaboration further sharpens AstraZeneca’s respiratory focus on Symbicort, Bevespi Aerosphere, benralizumab and other development programmesAstraZeneca today announced it has entered a strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the US. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD).

    AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia

    AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. Hyperkalaemia is characterised by high potassium levels in the blood serum. The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data. AstraZeneca and ZS Pharma are

    Fas III-studien SOLO-2 visar på förlängd progressionsfri överlevnad med Lynparza som underhållsbehandling av BRCA-muterad äggstockscancer

    Lynparza minskade risken för sjukdomsprogression med 70 %, med en prövarbedömd progressionsfri överlevnad på 19,1 månader, jämfört med 5,5 månader för placebo En blindad, oberoende central granskning visade en progressionsfri överlevnad på 30,2 månader, jämfört med 5,5 månader för placebo Lynparza-tabletterna uppvisade en säkerhetsprofil som generellt var i linje med tidigare studier, inklusive en låg förekomst av hematologisk toxicitetAstraZeneca presenterade idag resultaten från fas III-studien SOLO-2 som visade på en signifikant förbättring av den progressionsfria överlevnaden (PFS)

    Medimmune and Sanofi Pasteur form alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897

    MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly. MEDI8897 is a monoclonal antibody (mAb) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV), the most prevalent cause of LRTI among infants and young children. MEDI8897 is currently in a Phase IIb clinical trial in pre-term infants who are ineligible for Synagis, the current standard of care medicine, and the development plan includes a

    FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes

    Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar levelAstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.

    ZS-9 (sodium zirconium cyclosilicate) receives positive CHMP opinion for the treatment of hyperkalaemia

    AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia, a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases. The recommendation is based on data from three double-blind placebo-controlled trials and one ongoing 12-month open-label trial in adults with hyperkalaemia, representing over 1,600 patients

    AstraZeneca enters agreement with Tersera Therapeutics for Zoladex in the US and Canada

    AstraZeneca to receive upfront payment and sustainable and ongoing sales-based income Agreement expands the commercial potential of Zoladex in US and CanadaAstraZeneca today announced that it has entered into an agreement with TerSera Therapeutics LLC (TerSera) for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989. TerSera will pay AstraZeneca

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