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- Press release archive 2009
- 01 July 2009
- IRESSA (Gefitinib) Receives Marketing Authorisation for the Treatment of Non-Small Cell Lung Cancer in Europe AstraZeneca announced today that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy.
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- Press release archive 2009
- 30 June 2009
- AstraZeneca Development Partner, Pozen, Inc., Submits New Drug Application for PN400 AstraZeneca today announced that its development partner, Pozen, Inc., has submitted a New Drug Application to the US Food and Drug Administration for VIMOVO (PN400) (enteric coated naproxen /esomeprazole magnesium) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing NSAID-associated ulcers.
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- Press release archive 2009
- 25 June 2009
- ONGLYZA (saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes AstraZeneca and Bristol-Myers Squibb Company today announced that their marketing authorisation application for ONGLYZA (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
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- Press release archive 2009
- 10 June 2009
- Favourable Vote from FDA Advisory Committee on Seroquel Paediatric Supplemental New Drug Applications On 10 June 2009, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a review of the efficacy and safety of supplemental new drug applications (sNDAs) for SEROQUEL (quetiapine fumarate) proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age).
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- Press release archive 2009
- 04 June 2009
- AstraZeneca and Abbott Submit New Drug Application to the FDA for the Approval of CERTRIAD for the Treatment of Mixed Dyslipidemia AstraZeneca and Abbott announced today that the companies have submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL cholesterol (the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the “good” cholesterol).
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- Press release archive 2009
- 04 June 2009
- AstraZeneca and Abbott Extend Relationship to Include Co-Promotion of Trilipix AstraZeneca and Abbott announced today that they have entered into an agreement for AstraZeneca to co-promote Abbott’s TRILIPIX, a medication for use alone or in combination with a statin to treat certain lipid disorders.
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- Press release archive 2009
- 01 June 2009
- AstraZeneca and Merck & Co., Inc. Form Pioneering Collaboration to Investigate Novel Combination Anticancer Regimen AstraZeneca and Merck & Co., Inc. today announced a collaboration to research a novel combination anticancer regimen composed of two investigational compounds, MK-2206 from Merck and AZD6244 from AstraZeneca.
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- Press release archive 2009
- 29 May 2009
- AstraZeneca Regulatory Update on Seroquel XR for the Treatment of Major Depressive Disorder AstraZeneca today announced that the company has referred its application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of recurrent depressive episodes in adult patients with major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use (CHMP; a scientific committee of the European Medicines Agency, EMEA).
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- Press release archive 2009
- 20 May 2009
- Court Grants AstraZeneca Preliminary Injunction Against Apotex in Pulmicort Respules Patent Litigation On 20 May 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for an injunction barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES (budesonide inhalation suspension) in the US. No trial date for the patent litigation has been set.
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- Press release archive 2009
- 11 May 2009
- AstraZeneca Announces Top Line Results From Pivotal Phase III Study for BRILINTA AstraZeneca today announced top line results from the phase III trial, PLATO, which demonstrate that BRILINTA, the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS.
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At 03-Jul-2009 23:42 GMT
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