These press releases are for business and financial media.
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- 02 April 2003
- NEW CRESTOR® DATA AT ACC MEETING CONFIRM SUPERIOR PRODUCT PROFILE AstraZeneca today announced results from two international, large-scale clinical studies which further confirm that CRESTOR® (rosuvastatin) lowers LDL (or ‘bad’) cholesterol, raises HDL (or ‘good’) cholesterol, enabling more patients to achieve their cholesterol goals; better than the same and even some higher doses of other currently available treatments, including atorvastatin. Both studies, which add to the wealth of evidence in favour of CRESTOR, were presented at the American College of Cardiology
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- 02 April 2003
- NEW STUDY DEMONSTRATES THE POTENTIAL OF EXANTA™ (ximelagatran) FOR PREVENTION OF STROKE IN ATRIAL FIBRILLATION AstraZeneca today announced results from the first phase III stroke prevention data for Exanta™ (ximelagatran), the first of a new class of oral direct thrombin inhibitor (Oral DTI), presented at the 52nd Scientific Session of the American College of Cardiology (ACC), Chicago. The results show that fixed dose twice daily 36mg oral Exanta compares favourably with dose-adjusted warfarin in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), meeting the study’s
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- 01 April 2003
- ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM® IN THE FIRST OF FOUR INDICATIONS FOR THE MANAGEMENT OF NSAID*-ASSOCIATED GI SIDE EFFECTS AstraZeneca today announced the submission of a regulatory application to the United States Food and Drug Agency (FDA) for the first of four indications within the NSAID-associated gastrointestinal (GI) side effect programme for NEXIUM®. This first indication is for the use of NEXIUM® for the treatment of upper GI symptoms in patients taking NSAIDs. Applications for the indication are also currently being filed in Europe and Canada.
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- 24 March 2003
- NEW DATA BEING PRESENTED ON CRESTOR AND EXANTA: IMPORTANT DIARY DATE Data on two of AstraZeneca’s exciting new products, Crestor (rosuvastatin) and Exanta (ximelagatran), will be presented during the ACC (American College of Cardiology Congress).
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- 15 March 2003
- ASTRAZENECA LISTED IN BUSINESS IN THE COMMUNITY’S FIRST PUBLISHED CORPORATE RESPONSIBILITY INDEX AstraZeneca today announced that it has been listed as one of the top 20 companies in Business in the Community’s new Corporate Responsibility Index. This is the first business-led, voluntary index, publicly benchmarking the responsible business practice of a range of companies in different industry sectors. In addition, AstraZeneca improved its ranking in the Business in the Environment Index.
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- 10 March 2003
- SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR CRESTOR® IN EUROPE AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in Europe for CRESTOR® (rosuvastatin) 10-40 mg for the management of primary hypercholesterolaemia and mixed dyslipidaemia. The Netherlands acted as the reference member state for the MR procedure, and CRESTOR has been launched in that market. National marketing authorisations in an additional 13 countries will be issued in the coming months.
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- 03 March 2003
- FIRST EUROPEAN LAUNCH FOR CRESTOR® IN THE NETHERLANDS AstraZeneca announced today it has launched CRESTOR® (rosuvastatin) 10-40 mg for the management of primary hypercholesterolaemia and mixed dyslipidaemia in the Netherlands, the first European market to launch CRESTOR.
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- 27 February 2003
- ASTRAZENECA ISSUES 2002 ANNUAL REPORT AstraZeneca today published its Annual Report and Form 20-F for 2002. The document is available on our website. Download report
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- 19 February 2003
- ASTRAZENECA’S NEW STATIN, CRESTOR™, RECEIVES APPROVAL IN CANADA - COMPANY INTENDS IMMEDIATE LAUNCH AstraZeneca announced today it has received approval for CRESTOR™ (rosuvastatin) 10-40 mg from the Therapeutic Products Directorate of Health Canada for the management of primary hypercholesterolaemia, mixed dyslipidaemia, and familial hypercholesterolaemia in Canada. The company will launch CRESTOR in Canada immediately.
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- 18 February 2003
- ASTRAZENECA RESEARCH UPDATE ON AZD3582 AstraZeneca and NicOx today announced that AZD3582, in development for the treatment of acute and chronic nociceptive pain, showed efficacy in a recently completed Phase II clinical study, but did not reach its primary end point with respect to gastro-intestinal ulcers.
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- 17 February 2003
- RESULTS OF EXANTA™ (ximelagatran) TRIAL IN PREVENTION OF STROKE IN ATRIAL FIBRILLATION (SPORTIF III) TO BE PRESENTED AT ACC MEETING AstraZeneca announced today that headline results of the recently completed SPORTIF III (Stroke Prevention Oral Thrombin Inhibitor in Atrial Fibrillation) trial comparing Exanta™ (ximelagatran), with warfarin, the current standard of care, are encouraging. The data support the emerging positive benefit / risk profile for Exanta in this indication and will be presented in the Late-Breaking Clinical Trial section of the American College of Cardiology (ACC) meeting in Chicago on 2 April 2003.
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- 13 February 2003
- ASTRAZENECA SUBMITS INFORMATION AMENDMENT FOR CRESTOR® (ROSUVASTATIN CALCIUM) NDA TO FDA AstraZeneca announced today the submission of an information amendment to its New Drug Application (NDA) for CRESTOR® (rosuvastatin calcium) Tablets in response to the US Food and Drug Administration (FDA) approvable letter of May 2002.
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- 12 February 2003
- ASTRAZENECA ANNOUNCES A FURTHER $85M (£60.9M) INVESTMENT IN NEW CANCER RESEARCH BUILDING AstraZeneca today announced an $85m (£60.9m) investment in a new cancer research building - its largest single investment to date at Alderley Park, Cheshire.
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- 11 February 2003
- ASTRAZENECA SUBMITS IRESSA™ (gefitinib, ZD1839) FOR APPROVAL IN EUROPE FOR ADVANCED NON-SMALL CELL LUNG CANCER AstraZeneca announced today the submission in Europe of a Marketing Authorisation Application for IRESSA™ (gefitinib, ZD1839) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have failed prior chemotherapy. This follows the submission yesterday (4 February) of the European Marketing Authorisation Application for the use of FASLODEX™ (fulvestrant) in the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following
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- 11 February 2003
- BROTHERLY LOVE CAN MEND A HEART — IN MORE WAYS THAN ONE International Research Consortium—PROCARDIS—To Study Families’ Genes for Future Cardiovascular Therapies
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- 10 February 2003
- ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR SYMBICORT® TURBUHALER® IN COPD IN THE EUROPEAN UNION AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in the European Union for the use of the SYMBICORT® TURBUHALER® in the maintenance therapy of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of exacerbations. Sweden acted as the reference member state. SYMBICORT is already a leading therapy in the treatment of asthma, and is now set to gain European approval as a combined ß2-agonist and inhaled corticosteroid
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- 07 February 2003
- ASTRAZENECA SEEKS MANIA INDICATION FOR SEROQUEL® (QUETIAPINE) IN EUROPE The application to the European Health Authorities follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AstraZeneca to examine the efficacy and tolerability of SEROQUEL in this important disease area. The programme has delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm SEROQUEL to be an ideal first line agent. The application for a new license for SEROQUEL has been simultaneously submitted to the 14
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- 05 February 2003
- ASTRAZENECA SUBMITS FASLODEX® (fulvestrant) FOR APPROVAL IN EUROPE AstraZeneca announced today the submission in Europe of a Marketing Authorisation Application for the use of FASLODEX® (fulvestrant) in the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following prior endocrine therapy. FASLODEX was approved by the U.S. Food and Drug Administration in April 2002
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- 30 January 2003
- FOURTH QUARTER AND FULL YEAR RESULTS 2002 Download the narrative and the figures .
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- 09 January 2003
- ASTRAZENECA ANNOUNCES FDA REQUIRES MORE TIME FOR PRIORITY REVIEW OF IRESSA® (ZD1839) U.S. APPLICATION - DECISION EXPECTED BY MAY 5, 2003 The U.S. Food and Drug Administration (FDA) has notified AstraZeneca that it requires more time to review information requested of the company during the six month priority review of the new drug application (NDA) for IRESSA® (ZD1839/gefitinib). AstraZeneca will work closely with the agency to complete the review in a prompt and effective manner. The extended user fee goal date is May 5th 2003.
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- 08 January 2003
- ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR OXIS® TURBUHALER® IN COPD IN THE EUROPEAN UNION AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) in the European Union (France excluded) for the treatment of COPD with OXIS® TURBUHALER® as maintenance therapy, with additional doses as required, up to a maximum total daily dose of 36µg. Sweden acted as the reference member state.
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- 02 January 2003
- ASTRAZENECA FILES sNDA FOR SEROQUEL® (QUETIAPINE) IN BIPOLAR DISEASE AstraZeneca today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL® (quetiapine) for the treatment of acute mania associated with bipolar disorder (manic depressive illness).
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At Nov 21, 2009 10:43 AM GMT
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