These press releases are for business and financial media.
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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for Zactima (vandetanib) in combination with chemotherapy for advanced NSCLC AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer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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- 05 October 2009
- ONGLYZA (saxagliptin) Receives Marketing Authorisation in Europe for the Treatment of Type 2 Diabete AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for ONGLYZA (saxagliptin) in the 27 countries of the European Union.
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- 05 October 2009
- Study Finds That ONGLYZA (saxagliptin) When Added to Metformin was Non-Inferior to Januvia (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus Results from an 18-week phase IIIb study in adults with type 2 diabetes with inadequate glycemic control on metformin therapy alone found that the addition of treatment with ONGLYZA (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA (sitagliptin) 100 mg per day in reducing HbA1c from baseline.
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- 02 October 2009
- Dapagliflozen Study Demonstrated Significantly Improved Glycemic Control and Weight Reduction in Type 2 Diabetes Patients Inadequately Controlled with Metformin Results from a 24-week phase 3 clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin.
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- 29 September 2009
- Seroquel XR and Seroquel Approved in Europe for Prevention of Recurrence of Bipolar Disorder AstraZeneca announced today that once-daily SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.
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At 05-Nov-2009 21:45 GMT
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