Tag Archives: AstraZeneca

AstraZeneca Phase III PACIFIC trial: Imfinzi demonstrated statistically-significant and clinically-meaningful improvement in PFS

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 … Read the full press release

AstraZeneca Phase III FLAURA trial supports Tagrisso’s potential as a new standard of care in 1st-line EGFR-mutated lung cancer

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 … Read the full press release

MedImmune and Sanofi Pasteur to jointly develop and commercialise respiratory syncytial virus monoclonal antibody

LONDON, 03-Mar-2017 — /EuropaWire/ — MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly. MEDI8897 is a monoclonal antibody (mAb) for the … Read the full press release

AstraZeneca announce FDA approval of once-daily Qtern for the treatment of type-2 diabetes

Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level LONDON, 03-Mar-2017 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg … Read the full press release

AstraZeneca/ Karolinska Institutet research points to novel targets for next generation medicines for type 2 diabetes, obesity and other metabolic disorders

STOCKHOLM, 27-Sep-2016 — /EuropaWire/ — New understanding of how hormone-producing cells in the pancreas decode their genetic instructions is pointing to novel targets for next generation medicines for type 2 diabetes, obesity and other metabolic disorders. A large scale analysis of … Read the full press release

AstraZeneca announces positive CHMP opinion recommending the approval of new antibiotic, CAZ AVI

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release

AstraZeneca on Brilinta SOCRATES trial in stroke: safety data is consistent with the known safety profile of Brilinta/Brilique

Missed primary efficacy endpoint; fewer events observed in the Brilinta arm but trend did not reach statistical significance Consistent safety profile LONDON, 25-Mar-2016 — /EuropaWire/ — AstraZeneca today announced the top-line results of the SOCRATES trial, assessing the efficacy of Brilinta/Brilique(ticagrelor) 90mg … Read the full press release

AstraZeneca, Voluntis, US National Cancer Institute to test companion mobile app in ovarian cancer studies

LONDON, 10-12-2015 — /EuropaWire/ — AstraZeneca today announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. Voluntis has developed the service in close clinical … Read the full press release

AstraZeneca to present scientific abstracts from its cardiovascular and metabolic disease portfolio at European Society of Cardiology (ESC) Congress 2015 in London

LONDON, 31-8-2015 — /EuropaWire/ — Over 20 scientific abstracts from AstraZeneca’s cardiovascular and metabolic disease portfolio will be presented at this year’s European Society of Cardiology (ESC) Congress 2015 in London, including five oral presentations. Data being presented will focus … Read the full press release

Sanofi’s subsidiary Genzyme to acquire Caprelsa® (vandetanib) from AstraZeneca

Genzyme Strengthens Endocrinology Portfolio with Acquisition of Rare Disease Therapy Caprelsa®(vandetanib) from AstraZeneca Paris, France,  30-7-2015 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that it has entered into a definitive agreement with AstraZeneca to acquire Caprelsa® (vandetanib), a … Read the full press release

AstraZeneca and MedImmune presented encouraging results from their novel combination-focused immuno-oncology portfolio at ASCO Annual Meeting 2015

LONDON, 2-6-2015 — /EuropaWire/ — AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015. Overall, data indicated … Read the full press release

AstraZeneca announces that FDA accepted sNDA and granted Priority Review for BRILINTA® (ticagrelor) for patients with history of heart attack

LONDON, 4-5-2015 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for BRILINTA® (ticagrelor) tablets for patients with a history of heart attack. … Read the full press release

AstraZeneca and Eli Lilly to enrol more than 1,500 patients in 15 countries to their Phase II/III study of oral beta secretase cleaving enzyme (BACE) inhibitor in development as potential treatment for Alzheimer’s disease

Phase II/III trial of AZD3293, an oral potent small molecule inhibitor of BACE, aims to enrol more than 1,500 patients in 15 countries LONDON, 2-12-2014 — /EuropaWire/ — AstraZeneca and Eli Lilly and Company (Lilly) today announced enrolment of the … Read the full press release

AstraZeneca announced that the US FDA accepted for filing the New Drug Application for IRESSA® (gefitinib)

LONDON, 2-12-2014 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with … Read the full press release

AstraZeneca to present new data from its growing inflammation and autoimmunity portfolio at the American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, 14-19 November 2014

LONDON, 11-11-2014 — /EuropaWire/ — AstraZeneca, with its global biologics research and development arm, MedImmune, will present new data from the company’s growing inflammation and autoimmunity portfolio at the American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts, … Read the full press release

AstraZeneca: The Lancet Respiratory Medicine published encouraging safety and efficacy data from Benralizumab Phase II COPD study

Results are among key AstraZeneca respiratory data being presented at 2014 European Respiratory Society International Congress LONDON, 8-9-2014 — /EuropaWire/ — AstraZeneca today announced that The Lancet Respiratory Medicine has published encouraging safety and efficacy data from a Phase IIa … Read the full press release

AstraZeneca’s novel antibiotic candidate AZD0914 designated as Qualified Infectious Disease Product and awarded Fast Track status by US FDA

London, UK, 03-6-2014 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has designated its novel investigational drug AZD0914 as a Qualified Infectious Disease Product (QIDP) and awarded its development programme Fast Track status for the treatment … Read the full press release

AstraZeneca updates on the development of its oncology pipeline at the American Society of Clinical Oncology meeting in Chicago

London, UK, 03-6-2014 — /EuropaWire/ — AstraZeneca provided an update on the rapid development of its oncology pipeline at a briefing for analysts and investors on 2 June 2014, as compelling data from over 40 scientific abstracts related to AstraZeneca and MedImmune … Read the full press release

AstraZeneca PLC reports revenue up 3% at constant exchange rates in 2014 first quarter

London, UK, 25-4-2014 — /EuropaWire/ — Pascal Soriot, Chief Executive Officer, commenting on the results, said: “The first quarter has seen continued momentum across the business and our revenue growth reflects the increasing contribution from the five growth platforms that showed strong … Read the full press release

Karolinska Institutet appointed Professor Bo Angelin head of Integrated Cardio Metabolic Centre (ICMC)

Karolinska Institutet has appointed Professor Bo Angelin to lead the Integrated Cardio Metabolic Centre (ICMC), a joint initiative with AstraZeneca. Now it is a matter of recruiting scientists to the centre. Stockholm, Sweden, 21-11-2013 — /EuropaWire/ — Bo Angelin is a Professor … Read the full press release

AstraZeneca’s global biologics research and development arm MedImmune completed its acquisition of US-based Amplimmune for $225M plus $275M based on predetermined milestones

London, United Kingdom, 10-10-2013 — /EuropaWire/ — AstraZeneca today announced that on 4 October MedImmune, its global biologics research and development arm, completed its acquisition of Amplimmune, a privately-held, US-based biologics company focused on developing novel therapeutics in cancer immunology. As previously announced, … Read the full press release

AstraZeneca: temporary injunction against the US launch of Hanmi’s 505(b)2 NDA esomeprazole strontium lifted by Court of Appeals for the Federal Circuit (CAFC)

London, United Kingdom, 10-10-2013 — /EuropaWire/ — AstraZeneca today announced that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of Hanmi’s 505(b)2 NDA esomeprazole strontium product. AstraZeneca’s CAFC appeal of claim construction … Read the full press release

AstraZeneca, University of Cambridge and Cancer Research UK partner on 3 pre-clinical and clinical oncology projects

16-7-2013 — /europawire.eu/ — AstraZeneca today announced that it has entered into an agreement with the University of Cambridge and Cancer Research UK for a two-year collaboration on three pre-clinical and clinical oncology projects. This agreement with world-leading medical research institutions … Read the full press release

AstraZeneca Chief Financial Officer (CFO) and Executive Director Simon Lowth to leave the company at the end of October 2013

16-7-2013 — /europawire.eu/ — AstraZeneca today announced that Simon Lowth, Chief Financial Officer (CFO) and Executive Director, will leave the company at the end of October, after the reporting of third quarter results. Simon has been appointed CFO for the BG … Read the full press release

AstraZeneca announced it acquired 100% of Redwood City, Calif. based Pearl Therapeutics

28-6-2013 — /europawire.eu/ — AstraZeneca today announced that on 27 June 2013 it completed its acquisition of Pearl Therapeutics, a privately held company based in Redwood City, California, focused on the development of inhaled small-molecule therapeutics for respiratory disease.  Upon completion of … Read the full press release

MedImmune, NGM Biopharmaceuticals in exclusive agreement to discover, develop and commercialise therapies for diabetes and obesity

25-6-2013 — /europawire.eu/ — AstraZeneca today announced that MedImmune, its global biologics research and development arm, and NGM Biopharmaceuticals, Inc. have entered into an exclusive agreement to discover, develop and commercialise novel therapeutics from NGM’s enteroendocrine cell (EEC) programme for the … Read the full press release

AstraZeneca selects Cambridge Biomedical Campus for its new global R&D centre and corporate headquarters

Move brings AstraZeneca’s small molecule and MedImmune’s biologics research and development together at purpose-built facility on Cambridge Biomedical Campus 21-6-2013 — /europawire.eu/ — AstraZeneca today announced that its new UK-based global research and development centre and corporate headquarters will be located … Read the full press release

SAVOR-TIMI-53 cardiovascular outcomes trial of ONGLYZA® results announced by AstraZeneca and Bristol-Myers Squibb

20-6-2013 — /europawire.eu/ — AstraZeneca and Bristol-Myers Squibb announced today top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin). In this study of adult patients with … Read the full press release