These press releases are for business and financial media.
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- 19 December 2002
- FDA ADVISORY COMMITTEE REQUESTS FURTHER DATA ON ASTRAZENECA’S CASODEX® (BICALUTAMIDE) 150 MG FOR EARLY PROSTATE CANCER AstraZeneca announced today that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) did not recommend approval of the new indication for CASODEX 150 mg for the treatment of early stage prostate cancer. The panel recommendation does not impact on the current use and approval of CASODEX 50 mg formulation, and also does not impact on CASODEX 150 mg approvals in other countries.
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- 12 December 2002
- ASTRAZENECA WINS AUSTRALIA HIGH COURT APPEAL ON OMEPRAZOLE FORMULATION PATENT AstraZeneca today announced that the High Court of Australia has granted its appeal against an earlier Federal Court decision in a dispute with the generic pharmaceutical company, Alphapharm Pty Limited, about the validity of the formulation patent for omeprazole – the active substance used in Losec, a treatment for acid-related disorders, such as peptic ulcers.
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- 11 December 2002
- LATEST UPDATES FROM GROUNDBREAKING ATAC TRIAL CONFIRMS SUPERIORITY OF ARIMIDEX® OVER TAMOXIFEN IN EARLY BREAST CANCER AstraZeneca today announced from the San Antonio Breast Cancer Symposium in Texas, that the latest updates from the ATAC ( A rimidex, T amoxifen A lone or in C ombination) trial confirm the superior efficacy and favourable tolerability profile of ARIMIDEX over tamoxifen seen in as seen in the results reported last year.
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- 09 December 2002
- FIRST CHRONIC TREATMENT STUDY WITH ORAL EXANTA™ (XIMELAGATRAN) DEMONSTRATES HIGHLY SIGNIFICANT LONG TERM BENEFIT IN PREVENTING RECURRENT VENOUS THROMBOEMBOLISM (VTE) Additional data demonstrate superiority of EXANTA over both warfarin and enoxaparin in preventing VTE after major elective orthopaedic surgery
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- 06 December 2002
- NEW DATA DEMONSTRATES SYMBICORT® IS AN EFFECTIVE NEW TREATMENT FOR MODERATE TO SEVERE COPD AstraZeneca announced today that new data from a 12 month study presented at the British Thoracic Society (BTS) show that SYMBICORT® TURBUHALER® markedly reduces exacerbations and improves lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD), making it an important new treatment for this serious disease.
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- 26 November 2002
- ASTRAZENECA OPENS EAST ASIA CLINICAL RESEARCH CENTRE IN SHANGHAI AstraZeneca announced today the opening of its Clinical Research Unit-East Asia (ACRU-EA) in Shanghai.
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- 21 November 2002
- ASTRAZENECA APPOINTS NEW GROUP TREASURER Adrian Marsh will join AstraZeneca PLC, the international pharmaceuticals company, as Group Treasurer on January 1, 2003.
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- 14 November 2002
- ASTRAZENECA PLC – DIRECTORATE ANNOUNCEMENT AstraZeneca PLC today announced that Åke Stavling will be leaving the Company on 31 January 2003. Åke Stavling is 58 and has been an Executive Director since April 1999. He played a key role in the integration of Astra and Zeneca following the merger in 1999 and since then has been responsible for Business Development. From 1993-1999 he was Executive Vice President and Chief Financial Officer of Astra AB and before that held senior positions at Atlas Copco and Ericsson.
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- 07 November 2002
- ASTRAZENECA REPORTS SIGNIFICANT PROGRESS ACROSS ITS PROMISING RESEARCH AND DEVELOPMENT PORTFOLIO AstraZeneca today updated analysts on the company's late stage development products and projects; the progress of earlier stage products, notably in the cardio-vascular and oncology therapeutic areas; and the improved productivity in drug discovery, at its annual business review meeting in Alderley Park, Cheshire, UK, a centre of excellence for Oncology Research and Development at AstraZeneca.
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- 07 November 2002
- ASTRAZENECA’S NEW STATIN, CRESTOR™, RECEIVES FIRST APPROVAL IN EUROPE - Other European markets should follow in 2003 AstraZeneca announced today it has received the first approval for CRESTOR™ (rosuvastatin) 10-40 mg from the Medicines Evaluation Board (MEB) in the Netherlands for the management of primary hypercholesterolaemia and mixed dyslipidaemia.
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- 05 November 2002
- OMEPRAZOLE PATENT LITIGATION – ASTRAZENECA TO APPEAL US COURT’S JUDGEMENT RELATING TO KUDCo AND SCHWARZ PHARMA AstraZeneca’s initial detailed review of the Court’s October 11th 2002 opinion relating to KUDCo and Schwarz Pharma has revealed that the Court made reversible errors in determining key facts and applying the law. AstraZeneca has therefore decided to appeal the portions of the Court’s judgement relating to KUDCo and Schwarz Pharma.
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- 28 October 2002
- ASTRAZENECA’S NEW ORAL DIRECT THROMBIN INHIBITOR EXANTA™ SUPERIOR IN REDUCING RISK OF VENOUS THROMBOEMBOLISM (VTE) FOLLOWING TOTAL HIP OR KNEE REPLACEMENT SURGERY AstraZeneca announced today, from the 17th International Congress on Thrombosis (ICT) in Bologna, results from the EXPRESS phase III clinical trial with Exanta™ (oral ximelagatran and its active form, melagatran) that showed the drug’s superior efficacy in reducing risk of major venous thromboembolism (VTE) compared with a routinely used prophylactic treatment, enoxaparin, in major orthopaedic surgery.
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- 24 October 2002
- Third Quarter Results 2002 Download the narrative and the figures .
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- 22 October 2002
- ASTRAZENECA LOSES UK APPEAL ON OMEPRAZOLE FORMULATION PATENTS AstraZeneca today announced that the Court of Appeal in London has denied its request for a re-trial following an earlier decision of the United Kingdom’s Patents Court in a dispute with the generic pharmaceutical companies, Arrow Generics Limited (acting through Cairnstores Limited) and Generics UK Limited, about formulation patents for omeprazole – the active substance used in Losec, a treatment for acid-related disorders, such as peptic ulcers.
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- 25 September 2002
- FDA ADVISORY COMMITTEE VOTES IN FAVOUR OF ACCELERATED APPROVAL OF ASTRAZENECA’S IRESSA® (ZD1839) FOR ADVANCED NON-SMALL-CELL LUNG CANCER AstraZeneca announced today that the Oncology Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 11 to 3 that results in third line advanced non–small-cell lung cancer (NSCLC) were “reasonably likely to predict clinical benefit”, which the FDA indicated was a vote for accelerated approval for Iressa® (ZD1839) for the treatment of advanced NSCLC after disease progression following at least two chemotherapy agents (third line). The FDA will now review the ODAC
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- 16 September 2002
- NEW SYMBICORT® DATA SHOW PROMISE FOR DRUG IN TWO NEW SETTINGS - ADJUSTABLE DOSING FOR ASTHMA AND TREATMENT FOR COPD AstraZeneca announced today that new data presented at the 12th Annual Congress of the European Respiratory Society (ERS) show that adjustable dosing with Symbicort® provided effective asthma control using less drug overall than a fixed dosing regimen. An adjustable dosing approach with 'Symbicort' is a response to many asthma patients' needs and allows them to alter their dose according to disease variation using the same single inhaler. Additionally, nine poster presentations highlighted the ability of
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- 06 September 2002
- ASTRAZENECA GRANTED U.S. APPROVAL FOR ARIMIDEX® (anastrozole) IN EARLY BREAST CANCER AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved Arimidex® (anastrozole) for the adjuvant treatment of early breast cancer in postmenopausal women. The U.S. approval is based on the groundbreaking results from the ATAC ( A rimidex, T amoxifen, A lone or in C ombination) study-the world's largest ever breast cancer trial - which showed significant efficacy and tolerability benefits of 'Arimidex' over tamoxifen in this setting.
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- 01 September 2002
- NEW DATA SHOW CRESTOR® MORE EFFECTIVE THAN ATORVASTATIN ACROSS A WIDE RANGE OF DOSES AstraZeneca announced today that data presented at the European Society of Cardiology Meeting in Berlin, show that Crestor® (rosuvastatin) consistently achieved a significantly greater reduction in LDL-Cholesterol (LDL-C) levels when compared to atorvastatin across the dose range tested. This marks the first presentation of data demonstrating the superior LDL-C lowering capability of 'Crestor' when compared with atorvastatin across a range of doses. Previously presented data have been individual dose
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- 19 August 2002
- LUNG CANCER TRIAL RESULTS SHOW NO IMPROVEMENT FOR THE COMBINED TREATMENT OF IRESSA (ZD1839) WITH STANDARD PLATINUM-BASED CHEMOTHERAPY. AstraZeneca Continues Seeking Approvals for Iressa Monotherapy in Lung Cancer.
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- 07 August 2002
- ASTRAZENECA COMPLETES NEW DRUG APPLICATION TO THE FDA FOR IRESSA™(ZD1839) TO TREAT NON-SMALL CELL LUNG CANCER AstraZeneca announced today that the final documents of the New Drug Application (NDA), for IRESSA™(ZD1839) have been submitted to the U.S. Food and Drug Administration (FDA) completing the rolling submission for the drug that began last summer. All clinical data including safety and efficacy information was provided to the agency in December. IRESSA™is being considered as a monotherapy agent for the treatment of advanced non-small cell lung cancer (NSCLC) after disease progression following chemotherapy.
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- 06 August 2002
- ASTRAZENECA UPDATE ON CRESTOR Following a constructive meeting with the US Food and Drug Administration (FDA) to discuss the company's response to the approvable letter for Crestor (rosuvastatin calcium), AstraZeneca has undertaken to provide further information from its ongoing study programme to supplement that already submitted.
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- 25 July 2002
- Half Year and Second Quarter Results 2002 Download the narrative and the figures .
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- 09 July 2002
- WEALTH OF NEW DATA CONFIRMS EFFICACY AND SUITABILITY OF CRESTOR™ IN A WIDE-RANGE OF PATIENT POPULATIONS. More Patients Reach Target LDL-Cholesterol When Compared to Atorvastatin AstraZeneca announced today that the results of 14 data presentations for ‘Crestor’ (rosuvastatin) are being unveiled at the 73rd European Atherosclerosis Society congress in Salzburg, Austria this week. These include studies in comparisons with existing statins, which demonstrate that more patients reach target cholesterol levels with ‘Crestor’, in addition to other trials in a variety of patient populations.
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- 08 July 2002
- ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE FOR NEW PAEDIATRIC INDICATION FOR SYMBICORT® TURBUHALER® IN THE EUROPEAN UNION AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) for the use of Symbicort® Turbuhaler® as a maintenance treatment for asthma in children (age 6-11 years) in the European Union (EU), Iceland and Norway.
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- 05 July 2002
- ASTRAZENECA SECURES FIRST MARKET APPROVAL FOR IRESSA™ IN JAPAN AstraZeneca announced today that 'Iressa' (ZD1839, gefitinib) 250 mg once daily has received approval for the treatment of inoperable or recurrent non-small cell lung cancer (NSCLC) from the Japanese Ministry of Health, Labour and Welfare (MHLW), making Japan the first country worldwide to licence the drug. 'Iressa' is the first in a new class of anti-cancer drugs, known as Epidermal Growth Factor Receptor (EGFR) inhibitors, to become commercially available.
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- 26 June 2002
- 120,000 Swedish Twins Could Help Unlock the Secrets of the World's Diseases AstraZeneca to Collaborate with the Karolinska Institute on New Bio Bank
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- 21 June 2002
- ASTRAZENECA RESPONDS TO FDA ACTION ON SUPPLEMENTAL NEW DRUG APPLICATION FOR CASODEX 150MG FOR EARLY PROSTATE CANCER AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a non-approvable letter for its supplemental new drug application (sNDA) for 'Casodex' (bicalutamide) 150mg for the treatment of early prostate cancer. The FDA's decision does not impact on the current use and approval of 'Casodex' 50mg formulation for advanced prostate cancer treatment.
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- 17 June 2002
- ASTRAZENECA AND AVENTIS COLLABORATE ON CLINICAL TRIALS PROGRAM FOR IRESSA™ (ZD1839) IN COMBINATION WITH TAXOTERE® (DOCETAXEL) OR CAMPTO® (IRINOTECAN) 'Iressa', a once-daily, oral treatment, is a selective inhibitor of an enzyme known as EGFR-TK (epidermal growth factor receptor - tyrosine kinase), a new target for anti-cancer treatments, of which 'Iressa' is foremost in development. 'Iressa' specifically targets and blocks, within the cell, the activity of EGFR-TK, an enzyme that regulates intracellular signaling pathways implicated in cancer cell proliferation and survival. 'Iressa' is being developed by AstraZeneca and is not currently licensed in any
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- 14 June 2002
- AstraZeneca Opens New US$37.8 (£26) Million Tablets Expansion Facility To Cope With Growing Demand AstraZeneca today opened a new US$ 37.8 million tablets expansion facility at its manufacturing site in Macclesfield, Cheshire, to provide further launch and growth capacity for treatments for serious medical disorders. One of its initial roles is in the manufacture of 'Seroquel' (quetiapine), for the treatment of schizophrenia.
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- 06 June 2002
- AstraZeneca and Pierre Fabre collaborate on clinical trial programme for IRESSA™ (ZD1839) in combination with Vinorelbine (NAVELBINE® ORAL) AstraZeneca and Pierre Fabre today announced their clinical collaboration to evaluate the benefits of 'Iressa' (ZD1839) in combination with Vinorelbine (NAVELBINE® ORAL) for the treatment of advanced non small cell lung cancer. The clinical collaboration, which will be jointly funded by the Companies, will initially assess the combination of 'Iressa' with NAVELBINE® ORAL as part of a Phase I/II clinical trial programme involving patients with advanced stage non-small cell lung cancer (NSCLC), and will
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At 05-Nov-2009 21:45 GMT
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