These press releases are for business and financial media.
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- 19 November 2009
- AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor), an Investigational Antiplatelet Agent AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
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- 18 November 2009
- Results from Two Phase II Trials Add to Understanding of Brilinta (Ticagrelor) and How it Works in the Body AstraZeneca today announced the results of the phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (BRILINTA) at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL, with ONSET/OFFSET study results being simultaneously published in the medical journal Circulation.
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- 16 November 2009
- BRILINTA Demonstrated Greater Efficacy Over Clopidogrel in the Most Urgent Clinical Setting: Patients with ST-Segment Elevation Myocardial Infarction and Planned Percutaneous Coronary Intervention (PCI) AstraZeneca today announced results of a PLATO sub-analysis in the most serious type of Acute Coronary Syndrome (ACS) patients, those with ST Segment Elevation Myocardial Infarction (STEMI). In this setting, ST segment elevation indicates total obstruction of a coronary artery which warrants emergency surgery with angioplasty, a procedure termed primary Percutaneous Coronary Intervention or “PCI,” in order to restore flow, salvage the heart muscle (myocardium) from infarction and reduce mortality.
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- 13 November 2009
- Discovery Research Leader Leaves AstraZeneca AstraZeneca announced today that Jan M. Lundberg, Executive Vice President, Discovery Research has resigned to pursue other interests outside the company. Jan will step down from his operational role with immediate effect.
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- 29 October 2009
- AstraZeneca PLC Third Quarter & Nine Months Results 2009 Strong business performance has been driven by good operating execution bolstered by revenue upsides from Toprol-XL and H1N1 vaccine sales. Core EPS target for the year has been increased and progress has been made on the pipeline with the approval of ONGLYZA(TM), the European submission for Brilinta and new external collaborations, tempered by the disappointing news on Zactima.
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- 28 October 2009
- AstraZeneca withdraws regulatory submissions for Zactima (vandetanib) in combination with chemotherapy for advanced NSCLC AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009.
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- 19 October 2009
- Patients Taking VIMOVO(TM) Showed Decrease in incidence of NSAID Associated Ulcers AstraZeneca and POZEN Inc. today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.
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- 16 October 2009
- AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™ AstraZeneca and POZEN, Inc. today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO.
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- 16 October 2009
- SYMBICORT TURBUHALER Approved for the Treatment of Adult Asthma in Japan AstraZeneca today announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.
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- 16 October 2009
- US Food and Drug Administration Approves CRESTOR for Use in Pediatric Patients with Heterozygous Familial Hypercholesterolemia AstraZeneca today announced the US Food and Drug Administration (FDA) approved CRESTOR (rosuvastatin calcium) for use in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the “bad” cholesterol) and increased risk of early cardiovascular disease.
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At 20-Nov-2009 22:46 GMT
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