US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small cell lung cancer
Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation
Ämnen: Industri, tillverkning
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AstraZeneca shares its comprehensive scientific approach at the World Conference on Lung Cancer 2017
Early-stage disease - Quality-of-life results from the Imfinzi Phase III PACIFIC trial headline the Presidential Symposium Overcoming treatment resistance - Novel combination of Tagrisso and savolitinib provide potential new options for EGFRm patients with MET resistance
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The European Medicines Agency accepts marketing authorisation application for Imfinzi in locally-advanced unresectable non-small cell lung cancer
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
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Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive 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).
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TAGRISSO INGÅR I LÄKEMEDELSFÖRMÅNERNA
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).
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Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD
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
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Bydureon EXSCEL trial demonstrates favourable cardiovascular (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 Medicine
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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 US
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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.
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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 benefit
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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 s -
Förpackning märkt SelokenZOC 100 mg kan innehålla fel burk
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.
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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.
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Duaklir significantly improves lung function in COPD patients
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
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Tezepelumab significantly reduced asthma exacerbations for a broad population of patients with severe uncontrolled asthma
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
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AstraZeneca to present data on next generation of biologics at European Respiratory Society International Congress 2017
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.....
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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
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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 const -
Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer
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.
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Extended treatment with Brilinta reduces risk of cardiovascular death by 29% in patients with history of heart attack
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.
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