AstraZeneca och dess FoU-center för hematologi, Acerta Pharma, meddelar idag att den amerikanska läkemedelsmyndigheten FDA har godkänt Calquence(acalabrutinib) inom ramen för så kallat ”påskyndat godkännande” Calquence är en tyrosinkinashämmare och indikationen gäller behandling av vuxna patienter med mantelcellslymfom (MCL) som har fått minst en tidigare behandling. 1
AstraZeneca and MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation.
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US today announced that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza(olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise
Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer
Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation
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
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
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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