Update on Phase III clinical trials of lanabecestat for Alzheimer’s disease
Independent data monitoring committee advises lanabecestat is unlikely to meet primary endpoints, leading to decision to discontinue these trials
Ämnen: Industri, tillverkning
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The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer
Today the European Commission has granted marketing authorisation for Tagrisso as monotherapy for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. The approval is based on results from the Phase III FLAURA trial published in the New England Journal of Medicine.
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Lynparza in combination with abiraterone delayed disease progression in metastatic castration-resistant prostate cancer
AstraZeneca and Merck today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.
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Moxetumomab pasudotox pivotal data in patients with previously-treated hairy cell leukaemia presented at the 2018 ASCO meeting
Trial meets the primary endpoint of durable complete response Majority of patients who had a complete response had no evidence of any remaining detectable cancer cells Phase III clinical trial results served as basis for recent US FDA regulatory submission
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Update on TERRANOVA Phase III trial for Fasenra in chronic obstructive pulmonary disease
TERRANOVA trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease
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Imfinzi significantly improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-small cell lung cancer
AstraZeneca and MedImmune today announced positive overall survival results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi in patients with unresectable Stage III non-small cell lung cancer whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy.
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AstraZeneca heads to 2018 ASCO Annual Meeting with its diversified oncology portfolio and next-generation pipeline
AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 1-5 June 2018, with an expanded portfolio in Oncology.
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Regulatory submission in Japan for Forxiga in type-1 diabetes
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
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Lokelma approved in the US for the treatment of adults with hyperkalaemia
The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia,a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.
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AstraZeneca PLC:s resultatrapport för första kvartalet 2018
Bra lanseringar och resultat för våra nyare läkemedel stödjer oförändrad prognos
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New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma
AstraZeneca today announced results from the Phase III SYGMA trials of Symbicort Turbuhaler (budesonide/formoterol) given as an anti-inflammatory reliever ‘as needed’ versus two different treatment regimens in patients with mild asthma.
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AstraZeneca is advancing clinical practice in respiratory medicine with new data at the American Thoracic Society 2018 International Congress
AstraZeneca and MedImmune, its global biologics research and development arm, will present updates from its respiratory medicines and pipeline at the ATS 2018 International Congress, 18-23 May in San Diego, US. The breadth and depth of science are reflected in the 60 accepted abstracts, including five oral presentations, which focus on key areas of unmet need in asthma and COPD.
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AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease
GALATHEA Phase III trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD
Second Phase III trial TERRANOVA is ongoing with results expected later this quarter
AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab -
Lynparza tablets receive EU approval for the treatment of platinum-sensitive relapsed ovarian cancer
AstraZeneca and Merck & Co., Inc. today announced that the EMA has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
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AstraZeneca and Luye Pharma Group enter agreement for rights to Seroquel and Seroquel XR in the UK, China and other international markets
AstraZeneca has entered into an agreement with Luye Pharma Group, Ltd. (Luye Pharma) for the sale and licence of the rights to Seroquel and Seroquel XR in the UK, China and other international markets.
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Tagrisso receives positive EU CHMP opinion for 1st-line treatment of EGFR-mutated non-small cell lung cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
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Ny studie: Patienter med svår astma träffar sällan en läkare trots att varannan patient har en okontrollerad sjukdom
Inför Världsastmadagen 1 maj: I PACEHR-studien har fler än 18,500 astmapatienter i Sverige studerats. Majoriteten hade en lindrig och medelsvår astma och 790 personer hade svår astma. Data från 36 vårdcentraler runt om i Sverige jämfördes med uppgifter från hälsoregister under åren 2006-2013. Syftet med studien var att beskriva förekomst, samsjuklighet, dödlighet och behandling av svår astma.
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AstraZeneca reports results from the ARCTIC trial in third-line non-small cell lung cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments.
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US FDA approves Tagrisso as 1st-line treatment for EGFR-mutated non-small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.
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Updated overall survival data for Lynparza in BRCA-mutated HER2-negative metastatic breast cancer presented at AACR
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial showing the final overall survival (OS) results for Lynparza (olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, US, 14-18 April 2018.
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