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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 -

    New data on mechanisms of acquired resistance after 1st-line Tagrisso in NSCLC support initiation of ORCHARD trial to explore post-progression treatment options

    Phase III FLAURA trial shows MET-amplification and EGFR C797S mutation among most frequent resistance mechanismsAstraZeneca today presented new data on the mechanisms of acquired resistance from the Tagrisso (osimertinib) pivotal Phase III FLAURA trial during an oral late-breaker abstract session at the ESMO 2018 Congress (European Society of Medical Oncology) in Munich, Germany. MET-amplification and the epidermal growth factor receptor (EGFR) C797S mutation were among the most frequent resistance mechanisms observed after treatment with 1st-line Tagrisso in patients with previously-

    CHMP issues a positive opinion for Bevespi Aerosphere for the treatment of chronic obstructive pulmonary disease

    AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The CHMP recommendation is based on the Phase III PINNACLE programme, which demonstrated the efficacy and safety of Bevespi Aerosphere and involved more

    US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer

    Fourth Orphan Drug Designation in the US for AstraZeneca and MSD’s LynparzaAstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer. Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US.[i] 

    AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018

    More than 50 presentations, including data from the pivotal Phase III trial SOLO-1 selected for oral presentation in the ESMO Presidential Symposium New Lynparza data demonstrate clinically-meaningful improvement for newly-diagnosed, advanced BRCA-mutated ovarian cancer New data in NSCLC improve understanding of resistance mechanisms after 1st-line Tagrisso and evaluate treatment variations prior to Imfinzi in Stage III diseaseAstraZeneca and MedImmune, its global biologics research and development arm, will present 54 abstracts, including eight oral presentations and three late

    Christina Malmberg Hägerstrand ny presschef för AstraZeneca i Norden och Baltikum

    AstraZeneca meddelar i dag att man har anställt Christina Malmberg Hägerstrand i en ny roll som presschef för bolaget i Norden och Baltikum. Hon börjar den 7 januari 2019 och kommer rapportera till Kommunikationsdirektör Jacob Lund. Christina Malmberg Hägerstrand har lång erfarenhet från media och kommunikationsbranschen. Hon har arbetat som reporter på Dagens Industri och Nyhetsbyrån Direkt, nyhetschef på Di TV och som kommunikationschef på Nasdaq Nordic & Baltic. Hon kommer senast från en tjänst som chef för extern kommunikation och presschef på Alecta. Christina Malmberg

    Imfinzi is the first immunotherapy to demonstrate significant overall survival benefit in unresectable, Stage III lung cancer

    Imfinzi reduced the risk of death by nearly one third compared to standard of care in the Phase III PACIFIC trial Updated data reaffirm unprecedented improvement in progression-free survival of more than 11 monthsAstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results from the Phase III PACIFIC trial

    Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data

    Label now includes data that demonstrated favourable cardiovascular safety profile for patients with type-2 diabetes at wide range of cardiovascular riskAstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update for Bydureon (exenatide extended-release), to include in the European label cardiovascular (CV) data from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial in adults with type-2 diabetes at a wide range of CV risk. In EXSCEL,

    European Commission approves Imfinzi for locally-advanced, unresectable NSCLC

    Phase III PACIFIC trial demonstrated compelling overall survival benefit and progression-free survival of more than 11 months Imfinzi is the only immunotherapy medicine approved for the treatment of locally-advanced, unresectable NSCLCAstraZeneca and MedImmune, its global biologics research and development arm, today announced that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose

    Forxiga uppnådde ett positivt resultat i fas III-studien DECLARE TIMI 58, en stor kardiovaskulär studie med 17 000 patienter med typ 2-diabetes

    Forxiga mötte det primära sammansatta effektmåttet om en statistiskt signifikant reduktion av sjukhusinläggningar på grund av hjärtsvikt eller hjärtrelaterad död i en bred patientpopulation Resultaten bekräftade den väletablerade säkerhetsprofilen för ForxigaAstraZeneca meddelade i dag positiva övergripande resultat från den kardiovaskulära fas III-studien DECLARE-TIMI 58 for Forxiga (dapagliflozin), den bredaste kardiovaskulära studien hittills för en SGLT2-hämmare. Studien utvärderade de kardiovaskulära effekterna av Forxiga jämfört med placebo över en period på upp till fem år, i 33

    AstraZeneca presents further data showing the interconnectivity between cardiovascular and renal risks in diabetes at EASD 2018

    Head-to-head results of Farxiga vs. insulin or sulfonylurea in type-2 diabetes, withkey data on the safety and efficacy of Farxiga in both type-1 and type-2 diabetes  Results of 10 randomised trials from the DURATION clinical programme for Bydureon New data on MEDI0382, a potential first-in-classoxyntomodulin-like peptide for type-2 diabetesAstraZeneca and MedImmune, its global biologics research and development arm, will present more than 50 abstracts from the Company’s Cardiovascular, Renal & Metabolism (CVRM) therapy area at the 54th Annual Meeting of the European Association

    Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma

    74% of continuously-treated patients with a blood eosinophil count of 300 or greater were exacerbation-free in the second year of treatment Data presented at the European Respiratory Society (ERS) International Congress 2018AstraZeneca today announced results from the BORA Phase III extension trial evaluating the long-term safety and efficacy of Fasenra (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials. In the BORA trial, Fasenra given for an additional 56

    The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe COPD

    Data from the KRONOS trial presented at the European Respiratory Society (ERS) International Congress 2018AstraZeneca today announced publication of results from the KRONOS Phase III trial which evaluated the efficacy and safety of triple combination therapy PT010 (budesonide/ glycopyrronium/formoterol fumarate) versus dual combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Symbicort Turbuhaler (budesonide/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD)

    US FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukaemia

    Approval of Lumoxiti, a first-in-class medicine for hairy cell leukaemia marks first new treatment option for patients in over 20 years1 75% of patients receiving Lumoxiti achieved an overall response; 30% had a durable complete response2AstraZeneca and MedImmune, its global biologics research and development arm, announced today that the US Food and Drug Administration (FDA) has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including

    AstraZeneca to present Fasenra long-term safety and efficacy data at European Respiratory Society International Congress 2018

    BORA Phase III trial for Fasenra in severe eosinophilic asthma is among 43 company abstracts at the Congress, including nine oral presentationsAstraZeneca and MedImmune, its global biologics research and development arm, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris. A late-breaking oral presentation of the BORA Phase III trial evaluates the long-term safety and efficacy of

    Tezepelumab granted Breakthrough Therapy Designation by US FDA

    AstraZeneca’s first Breakthrough Therapy Designation for a respiratory medicine Designation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthmaAstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional

    Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus

    Trial did not meet the primary endpoint of a reduction of disease activity as measured by the SLE Responder IndexAstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months. Sean Bohen, Executive Vice President, Global

    European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes

    AstraZeneca today announced that the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes. The new formulation of once-weekly Bydureon is an improved single-dose, pre-filled pen device that requires no titration and is approved for use in combination with other glucose-lowering medicines, including basal insulin, to help improve glycaemic control in adults with type-

    AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease

    AstraZeneca today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In the trial, Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1. Dr Colin Reisner, Head of Respiratory, Global Medicines Development, said: “The efficacy and safety of Bevespi Aerosphere has been

    Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

    1st-line Tagrisso offers a potential new standard of care for Japanese lung cancer patientsAstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. The approval is based on results from the global Phase III FLAURA trial which included Japanese patients and which were published in the New England Journal of Medicine 

    AstraZeneca is advancing understanding of cardio-renal-metabolic interconnectivity with new evidence at ESC 2018

    New evidence of the persistency of ischaemic risk in post-heart attack patients, highlighting specific risk factors that may help identify patients for extended DAPT Latest data on the links between RAAS inhibitor dose reduction and increased risk of mortality and MACE in heart failure patients with hyperkalaemia First Phase IIa trial results on MEDI6012 in atherosclerosis, demonstrating cardio-protective potentialAstraZeneca and MedImmune, its global biologics research and development arm, will present new data from its Cardiovascular, Renal and Metabolism (CVRM) portfolio of

    Selumetinib granted orphan designation in Europe for neurofibromatosis type 1

    AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has granted orphan designation to 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 newborns worldwide.1,2 The severity of signs and symptoms associated with NF1 can be highly variable, are often mild-to-moderate and may include skin, nerve and skeletal manifestations. Plexiform neurofibromas (PNs) are benign tumours on nerve sheaths that

    Imfinzi receives positive EU CHMP opinion for locally- advanced, unresectable non-small cell lung cancer

    Recommended marketing authorisation for patients whose tumours express PD-L1 on ≥1% of tumour cells Imfinzi is the first immunotherapy recommended for approval for the treatment of locally-advanced, unresectable NSCLCAstraZeneca and MedImmune, its global biologics research and development arm, 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 Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in

    AstraZeneca PLC:s resultatrapport för första halvåret och andra kvartalet 2018

    Starka resultat från nya läkemedel och tillväxtmarknaderna stödjer återgång till tillväxt under 2018Stark försäljningsökning för nya läkemedel (+75%, +69% i fasta valutakurser[1]) och fortsatt stadig tillväxt på tillväxtmarknaderna (+14%, +10% i fasta valutakurser) under det första halvåret motverkades av effekterna av förlorad exklusivitet för Crestor i Europa och Japan. I linje med förväntningarna förutses förbättrade resultat under det andra halvåret, i synnerhet för produktförsäljningen, där prognosen om en låg ensiffrig procentuell ökning för helåret i fasta valutakurser bekräftas. Ett

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