These press releases are for business and financial media.
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- 23 December 2003
- EXANTA™ (XIMELAGATRAN) RECEIVES FIRST APPROVAL AstraZeneca has received its first regulatory approval for Exanta™ (ximelagatran) in France for the prevention of venous thromboembolic events in major orthopaedic (hip or knee replacement) surgery. France is the Reference Member State for the European Union (EU) Mutual Recognition Procedure for Exanta. Subject to approval, launches of Exanta in this first ‘proof of principle’ indication are expected to take place later in 2004.
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- 23 December 2003
- EXANTA™ (XIMELAGATRAN) REGULATORY FILINGS SUBMITTED IN UNITED STATES (US) AND EUROPEAN UNION (EU) FOR KEY CHRONIC INDICATIONS AstraZeneca has submitted Exanta™ the first oral direct thrombin inhibitor, for regulatory review in the EU and US in key chronic-use indications. In the US, submissions have been made to the Food and Drug Administration (FDA) for Exanta in the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF) and long-term secondary prevention of venous thromboembolism (VTE), after standard treatment for an episode of acute VTE. In Europe, regulatory submissions have been
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- 19 December 2003
- ASTRAZENECA AND ARRAY BIOPHARMA ANNOUNCE ONCOLOGY COLLABORATION AstraZeneca and Array BioPharma today announced a licensing and collaboration agreement to develop Array’s MEK programme in the field of oncology. The programme includes the clinical development candidate (ARRY-142886) and related intellectual property.
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- 12 December 2003
- ASTRAZENECA PRILOSEC® PATENTS UPHELD BY FEDERAL APPEALS COURT AstraZeneca today announced that a three judge panel of the United States Court of Appeals for the Federal Circuit upheld the October 2002 decision by U.S. District Court Judge Barbara S. Jones, finding that Andrx, Genpharm and Cheminor infringed AstraZeneca’s patents for Prilosec® (omeprazole), and that the two formulation patents are not invalid. The Court also upheld the judgment that Kudco’s formulation did not infringe.
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- 11 December 2003
- EUROPEAN COURT JUDGMENT DOES NOT SUPPORT ASTRAZENECA IN OMEPRAZOLE PATENT CASE AstraZeneca today announced that the European Court of Justice had ruled against its arguments in a case relating to the duration of patent protection for omeprazole, the active ingredient in Losec, the anti-secretory treatment.
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- 09 December 2003
- FURTHER DATA SUPPORTS SAFETY AND EFFICACY OF ORAL DIRECT THROMBIN INHIBITOR, EXANTA™ (XIMELAGATRAN) IN PREVENTION OF VENOUS THROMBOEMBOLISM AstraZeneca today announced further evidence to support the efficacy and safety profile of Exanta™ (ximelagatran), following a presentation at the American Society of Haematology (ASH) Annual Meeting 2003, San Diego, US
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- 09 December 2003
- ASTRAZENECA SUBMITS REGULATORY APPLICATION FOR SYMBICORT® TURBUHALER® FOR THE MANAGEMENT OF ASTHMA WITH ONE SINGLE INHALER (SYMBICORT® SINGLE INHALER THERAPY) AstraZeneca announced today the submission of an EU regulatory application for the new asthma treatment concept Symbicort® Single inhaler Therapy (SiT). Symbicort® SiT is the management of persistent asthma with a single inhaler, Symbicort® Turbuhaler®. This new treatment concept is a further development of Symbicort® adjustable maintenance dosing, which has already shown overall better asthma control than treatment with a higher average fixed maintenance dose. Symbicort® Single inhaler Therapy, once
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- 03 December 2003
- ARIMIDEX™ CHALLENGES TAMOXIFEN AS STANDARD ADJUVANT THERAPY IN POSTMENOPAUSAL WOMEN WITH EARLY BREAST CANCER New data, announced today at the San Antonio Breast Cancer Symposium, USA, questions the role of tamoxifen as standard adjuvant therapy for postmenopausal women with hormone-sensitive early breast cancer. The ITA (Intergruppo Tamoxifen Anastrozole) Trial data suggests that patients who change their adjuvant therapy from tamoxifen to ‘ARIMIDEX’™ after two - three years, are less likely to experience a return of breast cancer than those who complete a five year course of tamoxifen. In addition, those
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- 03 December 2003
- ASTRAZENECA COMMITS TO PARTNERING WITH INNOVATIVE EDUCATIONAL PROGRAMME AND SUPPORTING CHINA’S HEALTHCARE REFORM OVER THE LONG TERM AstraZeneca today announced a collaboration with Peking University’s (PKU) Guanghua School of Management (GSM) to fund the China Center for Pharmacoeconomics and Outcomes Research (CCPOR) in a series of research and educational programmes aimed at supporting reform of China’s healthcare system.
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- 21 November 2003
- POSITIVE OPINION GIVEN ON APPROVABILITY OF FASLODEX™ (FULVESTRANT) IN EUROPEAN UNION (EU) AstraZeneca announced today that it has received a positive opinion on EU marketing approval of its breast cancer therapy Faslodex™ (fulvestrant) from the Committee for Proprietary Medicinal Products (CPMP), scientific advisory body to the European Commission. The CPMP concluded that, on the basis of the quality of safety and efficacy data submitted, ‘there is a favourable risk balance for Faslodex and therefore recommends the granting of the marketing authorisation.’
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- 17 November 2003
- ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR HIGH DOSE RANGE OF SYMBICORT® TURBUHALER® AstraZeneca announced today that it has successfully completed the European Union Mutual Recognition Procedure for Symbicort® Turbuhaler®, which permits the use of an increased dose range in some patients with persistent asthma. National licences are expected to be issued throughout the EU over the coming months and will allow patients to use up to four inhalations twice daily of the 80/4.5mg and 160/4.5mg strengths (or two inhalations twice daily of the 320/9mg strength).
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- 11 November 2003
- NEW STUDY CONFIRMS POTENTIAL FOR EXANTA™ (ximelagatran) IN PREVENTION OF STROKE IN ATRIAL FIBRILLATION AstraZeneca today announced the results from the SPORTIF V study at the American Heart Association (AHA) Scientific Sessions 2003, in Orlando, US. The data supports the potential for Exanta™ (ximelagatran), the first oral treatment in a new class of direct thrombin inhibitors (DTIs), to be an effective and predictable replacement for warfarin in the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), without the limitations of warfarin treatment.
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- 30 October 2003
- ASTRAZENECA RECEIVES FDA APPROVABLE LETTER FOR SEROQUEL™ (QUETIAPINE FUMARATE) TABLETS IN TREATMENT OF MANIA AstraZeneca today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its Supplemental New Drug Applications (sNDAs) for the use of SEROQUEL as both an adjunct and monotherapy for the treatment of manic episodes associated with bipolar disorder. The company is working closely with the FDA to supply information and to finalize labelling.
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- 23 October 2003
- ASTRAZENECA PLC THIRD QUARTER AND NINE MONTHS RESULTS “Strong quarter contributes to a 2 percent increase in nine months sales; Key growth products up 56 percent; Full year earnings expected at or just above top of forecast range."
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- 16 October 2003
- ASTRAZENECA AND ABGENIX ANNOUNCE STRATEGIC ALLIANCE TO DISCOVER AND DEVELOP ANTIBODY THERAPEUTICS FOR CANCER London and Fremont, CA –AstraZeneca and Abgenix, Inc. (Nasdaq: ABGX) announced today that they have entered into a broad collaboration, license and investment alliance to discover, develop and commercialise fully human monoclonal antibodies to treat cancer.
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- 13 October 2003
- ASTRAZENECA RECEIVES EUROPEAN APPROVAL FOR SEROQUEL™ IN BIPOLAR MANIA AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of SEROQUEL (quetiapine) to the treatment of mania associated with bipolar disorder (manic-depressive illness). SEROQUEL is also under review for bipolar mania in the United States with the Food and Drug Administration (FDA) and in the UK with the Medicines and Healthcare products Regulatory Agency (MHRA).
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- 02 October 2003
- ASTRAZENECA SET TO DELIVER TOP-TIER FINANCIAL PERFORMANCE THROUGH US MARKETING AND R&D SUCCESS CRESTOR and IRESSA US Launches Show Early Promise London – 2 October 2003 – AstraZeneca is well positioned to compete in the dynamic, US marketplace where the demand for new, innovative medicines continues to be strong, the company’s executives reported today at its Annual Business Review.
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- 30 September 2003
- Large differences in lung deposition between dry powder inhalers in children Results from a study published in the October 1st issue of American Journal of Respiratory and Critical Care Medicine suggest that there are large differences in lung delivery in asthmatic children between the two dry powder inhalers Turbuhaler® and Diskus®.
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- 26 September 2003
- Welcome to the Symbicort "My Personal Best" media event Monday 29 September, 9.30 CET. At the "My Personal Best" media event Olympic gold medallist Cathy Freeman will speak about her personal experience of asthma. New data showing that adjustable dosing is superior to fixed dosing will be presented. All materials from the event will be available from 9.30 CET.
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- 17 September 2003
- NEW DATA INDICATE THAT POSTMENOPAUSAL WOMEN WITH HORMONE-SENSITIVE, EARLY BREAST CANCER ARE LESS LIKELY TO RELAPSE IF THEIR ADJUVANT THERAPY IS CHANGED FROM TAMOXIFEN TO ARIMIDEX™ (ANASTROZOLE) For the attention of medical correspondents only Nottingham, UK. Wednesday 17 September 2003: New data were presented for the first time today which indicate that patients who have their adjuvant therapy changed from tamoxifen to ARIMIDEX TM (anastrozole) are less likely to experience a relapse of the disease than patients who remain on tamoxifen. Furthermore, changing therapy to anastrozole resulted in fewer serious adverse events than continued tamoxifen treatment 1 . The data, presented at the 8th
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- 17 September 2003
- New data on hormonal therapy with goserelin challenge the role of chemotherapy for treatment of breast cancer in younger women overwhelming preference for goserelin (‘Zoladex’) therapy over chemotherapy demonstrated by healthy younger women · goserelin is as effective as standard chemotherapy* without the distressing side effects in premenopausal women with hormone-sensitive early breast cancer · when added to tamoxifen, goserelin therapy is more effective than chemotherapy in these patients. For the attention of health, science and news correspondents Nottingham, UK, Wednesday 17 September 2003: Newly published research
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- 17 September 2003
- New data suggest tamoxifen may no longer offer women the best chance of remaining free from their breast cancer Women who have their therapy changed from tamoxifen to anastrozole appear less likely to have their cancer return or to suffer from serious side effects than those who stay on tamoxifen For the attention of medical correspondents and healthcare / science writers Nottingham, UK. September 17th 2003: New clinical trial data presented today at a major international breast cancer conference provide further evidence that there is now a highly effective and well-tolerated alternative to tamoxifen, available for
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- 17 September 2003
- ‘Zoladex’ (goserelin) is an effective alternative to chemotherapy, with significant tolerability benefits for younger women with early breast cancer new data confirm that ‘Zoladex’ is as effective as standard chemotherapy* in premenopausal women with hormone-sensitive tumours. When combined with tamoxifen, ‘Zoladex’ is significantly more effective than chemotherapy in these patients. new research demonstrates that healthy premenopausal women have an overwhelming preference for ‘Zoladex’ over chemotherapy For the attention of medical correspondents only Nottingham, UK, Wednesday 17 September 2003: New survival data from two key trials, presented
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- 11 September 2003
- ASTRAZENECA SUBMITS NEXIUM® INTRAVENOUS FORMULATION TO FDA FOR REGULATORY APPROVAL AstraZeneca today announced submission of the new Nexium® (esomeprazole sodium) intravenous (i.v.) formulation for regulatory approval by the US Food and Drug Administration (FDA).
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- 08 September 2003
- NEW STUDY SHOWS SYMBICORT® ADJUSTABLE DOSING PROVIDES BETTER ASTHMA CONTROL THAN SERETIDE® FIXED DOSING AstraZeneca announced today that new data presented at the World Allergy Organization’s International Congress of Allergology and Clinical Immunology (ICACI) show that the rate of severe exacerbations is 40 per cent lower in asthma patients on Symbicort® adjustable dosing than in patients on Seretide® fixed dosing. These are the first head-to-head data on the two fastest growing brands in asthma treatment.
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- 03 September 2003
- Similar anti-asthmatic activity of budesonide via Turbuhaler® and fluticasone via Diskus® LUND, September 3; According to a new study the two inhaled steroids budesonide and fluticasone delivered via their respective dry powder inhalers (Pulmicort® Turbuhaler® and Flixotide™ Diskus™) excert similar anti-asthmatic activity on a microgram to microgram basis.
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- 02 September 2003
- CRESTOR Webcast, 2 October, 11.00 CET Staying Ahead in Cardiovascular Disease Risk Reduction: CRESTOR™ Data Today and Tomorrow This webcast is for non-Japanese journalists only
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- 02 September 2003
- LARGEST-EVER STROKE PREVENTION STUDY IN ATRIAL FIBRILLATION SHOWS POTENTIAL FOR EXANTA™ (XIMELAGATRAN) IN MAJOR INDICATION Latest data from the full presentation today of the SPORTIF III study at the European Society of Cardiology (ESC), Vienna, Austria, shows clinical benefit for Exanta (ximelagatran), the first in a new class of oral direct thrombin inhibitors (oral DTIs), compared with the current standard treatment, dose-adjusted warfarin, in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
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- 01 September 2003
- NEW DATA DEMONSTRATES CLEAR BENEFITS OF ATACAND® IN TREATMENT OF SYMPTOMATIC HEART FAILURE Atacand®, the only Angiotensin Receptor Blocker to reduce cardiovascular death and hospitalisation in chronic heart failure when given together with conventional therapy AstraZeneca announced today that data presented at the European Society of Cardiology annual meeting demonstrated Atacand® (candesartan cilexetil) reduces both cardiovascular deaths as well as hospital admissions for heart failure, across a broad spectrum of patients with chronic heart failure.
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- 01 September 2003
- PHASE II STUDY DEMONSTRATES PROMISE FOR EXANTA™ (XIMELAGATRAN) IN REDUCING MAJOR CARDIOVASCULAR EVENTS FOLLOWING MYOCARDIAL INFARCTION (MI) ESTEEM* study indicates potential for Exanta in new cardiovascular indication AstraZeneca announced today from the European Society of Cardiology (ESC) in Vienna, Austria, that data from a phase II dose-guiding study, ESTEEM*, indicate that oral Exanta™ (ximelagatran), provides significant additional benefits compared to the current treatment, aspirin, in prevention of major cardiovascular events in patients following an acute myocardial infarction (heart attack). This is the first time an oral direct
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