US FDA accepts first biologics license application for AstraZeneca’s durvalumab in bladder cancer
FDA grants priority review status with PDUFA set for Q2 2017
Ämnen: Farmaci
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Tagrisso (osimertinib) visar på förbättrade resultat vid EGFR T790M icke småcellig lungcancer jämfört med cytostatika
Den första randomiserade fas 3-studien (AURA3) som jämför osimertinib med dubbel platinumbaserad cytostatikabehandling Osimertinib förbättrade progressionsfri överlevnad med nästan sex månader Patienter med metastaser på centrala nervsystemet visade på liknande resultat som den totala populationen enligt förbestämda subgruppsanalyser
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AstraZeneca takes latest scientific advances in oncology to major US and European congresses
Tagrisso scientific updates include results of AURA3 trial in patients with lung cancer, and Phase II efficacy data on CNS metastases New analyses of Phase III FALCON trial will extend understanding of Faslodex in 1st-line treatment of advanced breast cancer New acalabrutinib safety and efficacy data in patients with difficult-to-treat chronic lymphocytic leukaemia
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AstraZeneca head and neck cancer trials resume new patient enrolment as FDA lifts partial clinical hold
AstraZeneca today announced that the US FDA has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.
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AstraZeneca uppmärksammar Världsdiabetesdagen den 14 november
Korta fakta om diabetes - en växande folksjukdom. AstraZeneca har som mål att förbättra livet för personer med diabetes genom att minska påverkan av sjukdomen och dess komplikationer. Vi forskar inom metabola sjukdomar och har en ambition att vara ledande på området. AstraZeneca erbjuder olika behandlingsmöjligheter inom typ 2-diabetes.
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AstraZeneca PLC:s resultatrapport för de första nio månaderna och tredje kvartalet 2016
Resultatet för tredje kvartalet är i linje med våra förväntningar
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Lynparza Phase III SOLO-2 trial shows significant progression-free survival benefit
Trial studied Lynparza as maintenance treatment for women with BRCA-mutated metastatic ovarian cancer Initial findings show safety profile with Lynparza tablets was consistent with previous studies
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FDA accepts for review New Drug Application for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalaemia
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2
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AstraZeneca enters agreement with Cilag GmbH International to divest rights to Rhinocort Aqua outside the US
AstraZeneca today announced that it has entered into an agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the US.
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AstraZeneca enters agreement with Aralez for beta-blocker medicine Toprol-XL in the US
AstraZeneca today announced that it has entered into an agreement with Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez Pharmaceuticals Inc., for the rights to branded and authorised generic Toprol-XL (metoprolol succinate) in the US
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AstraZeneca reports top-line results from the Brilinta EUCLID trial in patients with peripheral artery disease
Brilinta did not demonstrate a benefit over clopidogrel in a symptomatic peripheral artery disease patient population
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MedImmune out-licenses potential medicine for inflammatory diseases to Allergan
AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a licensing agreement with Allergan plc for the global rights to MEDI2070.
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AstraZeneca presents new data on Faslodex in breast cancer and provides immuno-oncology update at ESMO 2016 congress
Phase III FALCON trial demonstrates superiority of Faslodex over Arimidex in the 1st-line treatment of hormone-receptor positive (HR+) advanced breast cancer Immuno-Oncology data reinforce commitment to lung and head and neck cancers
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AstraZeneca provides update on cediranib EU marketing authorisation application
AstraZeneca today announced its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy
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Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes
DURATION-8 trial met primary and secondary endpoints, significantly reducing blood sugar (HbA1c), weight and systolic blood pressure versus either medicine alone The first trial to assess GLP-1RA/SGLT-2i combination therapy
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Stora skillnader i vården av typ-2 diabetes i Danmark, Norge och Sverige enligt ny studie som presenteras på EASD
Kontrollen av blodsocker och kolesterol hos patienter med typ 2-diabetes är bättre i Danmark jämfört med i Norge och i Sverige enligt resultat från studien Nordic DISCOVER. Studien är den första nordiska jämförande långsiktiga studien av primärvårdens omhändertagande av patienter med typ 2-diabetes. Resultat presenteras för första gången på den europeiska diabeteskonferensen EASD, 14 september.
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Fördubblade sjukdomskostnader i Sverige för typ 2-diabetes under åren 2006 – 2014. Följdsjukdomar som stroke och hjärtinfarkt kostar allt mer
Sjukdomskostnaderna för behandling av patienter med typ 2-diabetes fördubblades i Sverige mellan åren 2006 och 2014 samtidigt som kostnaderna för diabetesläkemedel genomgående under perioden endast representerar fyra procent. Det visar resultat från den svenska studien DAISY som presenteras på den europeiska diabeteskonferensen EASD, den 13 september.
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AstraZeneca announces two new phase IIIb trials for Forxiga in chronic kidney disease and chronic heart failure
First programme to assess potential cardiovascular and renal benefit of an SGLT-2i beyond diabetes
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Benralizumab Phase III trials show positive results in severe asthma
AstraZeneca’s first biologic respiratory medicine met primary and key secondary endpoints in pivotal trials for severe asthma
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AstraZeneca to present new data highlighting its growing respiratory portfolio and pipeline at European Respiratory Society 2016
New evidence to be presented includes pivotal Phase III data on benralizumab
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