AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Tandvårds- och läkemedelsförmånsverket, TLV, har beslutat att AstraZenecas läkemedel Tagrisso® (osimertinib) från och med den 1 oktober ingår i läkemedelsförmånerna för vuxna patienter med lokalt avancerad eller metastaserad epidermal tillväxtfaktorreceptor (EGFR) T790M mutationspositiv icke-småcellig lungcancer (NSCLC).
hase 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 China
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 Medicine
Agreement builds on 2016 collaboration on commercialisation rights to anaesthetic medicines in markets outside the US
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.
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 benefit
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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 s
Vi vill uppmärksamma patienter som hämtat ut en förpackning med SelokenZOC 100 mg i burk med 100 tabletter, efter april i år, att kontrollera att den burk som ligger i förpackningen verkligen är märkt SelokenZOC 100 mg. Aktuellt varunummer är Vnr 543587, batchnummer VBBN.
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.
Phase III AMPLIFY trial demonstrateda statistically significant improvement in lung function in patients with COPD Study achieved the primary endpoints to support a New Drug Application (NDA) submission
AstraZeneca 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, uncontrolled asthma
AstraZeneca 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 Milan, Italy. The breadth and depth of science are reflected in the 48 accepted abstracts.....
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
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 const
AstraZeneca 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.
AstraZeneca 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.
AstraZeneca 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).
Resultat publicerade i The Lancet Diabetes & Endocrinology från observationsstudien CVD-REAL Nordic, baserad på svenska registerdata, 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.