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
Tuesday, 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.
Friday, 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.
Friday, 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.
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
Friday, 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.’
This website is intended for people seeking information on AstraZeneca's International business. We also have national business sites; links to these are under 'Other AZ websites' at the top of the page.