|
14 May 2008
FDA Approves AstraZeneca’s Seroquel for Maintenance Treatment in Bipolar Disorder |
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL® (quetiapine fumarate) for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex. SEROQUEL is approved by the FDA for the treatment of schizophrenia, and is also the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder.
|
 |
8 May 2008
AstraZeneca Submits sNDA for Seroquel XR™ for the Treatment of Generalised Anxiety Disorder – a First for the Atypical Antipsychotic Class of Medicines |
AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of generalised anxiety disorder (GAD), including maintenance of antianxiety effect. It is the first time approval has been sought for an atypical antipsychotic medicine in GAD.
|
|
6 May 2008
EPO Announces Symbicort® European COPD Use Patent Decision |
AstraZeneca today announced that the European Patent Office (EPO) Technical Board of Appeal has made a final ruling that the European Combination patent covering the use of Symbicort® (formoterol and budesonide) for the treatment of chronic obstructive pulmonary disease (COPD) (EPB1014993) has been revoked, following an appeal from generic manufacturers Norton Healthcare and Generics UK.
|
|
2 May 2008
AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA™) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer |
AstraZeneca today announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.
|
|
30 April 2008
AstraZeneca Submits sNDA for SYMBICORT® for COPD Treatment |
AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
|
|
24 April 2008
AstraZeneca PLC First Quarter Results 2008 |
|
|
15 April 2008
AstraZeneca Settles US Nexium Patent Litigation with Ranbaxy |
Companies Also Sign Manufacturing and Distribution Agreements
AstraZeneca today announced it has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its affiliates (“Ranbaxy”).
|
|
31 March 2008
Crestor Outcomes Study JUPITER Closes Early Due To Unequivocal Evidence Of Benefit |
AstraZeneca today announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.
|
|
13 March 2008
AstraZeneca and Silence Therapeutics To Collaborate On Novel Approaches For siRNA Drug Delivery |
AstraZeneca today announced a collaboration with Silence Therapeutics plc, focused on the development of a range of novel approaches for the delivery of short interfering ribonucleic acid (siRNA) molecules. The deal builds on Silence Therapeutics’ expertise in the delivery of siRNA molecules, in particular its success with the functional systemic delivery of siRNA in vivo using its proprietary AtuPLEX technology. The financial details of this collaboration, in which both parties will contribute expertise, have not been disclosed.
|
|
12 March 2008
Trial Date Set For SEROQUEL® Patent Litigation |
AstraZeneca today announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (ANDAs). The ANDAs seek approval to market generic versions of SEROQUEL® (quetiapine fumarate tablets) in the US before SEROQUEL’s patent expires in 2011. The Court has set a date for trial beginning on 11 August 2008.
|
|
11 March 2008
Clinical Oncology Publishes Findings from First-Ever Initiative on Sustainable Breast Cancer Treatment in the Developing World |
In response to the growing burden of cancer in the developing world, AstraZeneca, in partnership with Tikur Anbessa Hospital, Addis Ababa, The Ethiopian Ministry of Health and AXIOS, developed a framework two years ago for the first-ever programme to raise awareness, diagnose and treat breast cancer in Ethiopia. The interim results of this five-year initiative are reported in the March edition of Clinical Oncology*.
|
|
6 March 2008
AstraZeneca Issues 2007 Annual Report |
AstraZeneca has today published its Annual Report and Form 20-F Information 2007. The Report is available as a dedicated website at:
www.astrazeneca.com/annualreport2007 (which includes a downloadable PDF version) and as a printed document. Our summary corporate responsibility (CR) report has been integrated into the Report and full CR information continues to be available online at: www.astrazeneca.com/responsibility.
|
|
29 February 2008
AstraZeneca Submits sNDA for Seroquel XR™ for the Treatment of Major Depressive Disorder |
AstraZeneca today announced submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.
|
|
28 February 2008
AstraZeneca Provides An Update on the Status of its Arrangements With Merck & Co., Inc. |
AstraZeneca today announced that, under the provisions of the agreements relating to the restructuring of the AstraZeneca and Merck & Co. joint venture in the United States, AstraZeneca has been informed that Merck has elected not to exercise the First Option related to the relinquishment of Merck’s rights over the products not covered by the Partial Retirement (see paragraph below), other than Nexium™ and Prilosec™. As a result of this decision, contingent payments will continue on the products Atacand™, Lexxel™, Plendil™ and Entocort™ until at least 2010, at which time AstraZeneca may exercise this option at the 2008 Appraised Value of approximately $650 million. The Appraised Value also includes rights to certain products that are still in clinical development (AZD6140, AZD3355, AZD0328 and AZD2327). AstraZeneca made contingent payments in respect of the products included in the First Option of $69 million in 2007.
|
|
27 February 2008
AstraZeneca Provides Update On RECENTIN™ Clinical Development Programme |
HORIZON Colorectal Cancer Programme Continues Into Phase III; BR24 Non-Small Cell Lung Cancer Trial Will Not Progress
AstraZeneca today announced that its HORIZON III Phase II/III head-to-head study of RECENTIN™ (cediranib, AZD2171) with chemotherapy versus bevacizumab (Avastin™) with chemotherapy in patients with first line metastatic colorectal cancer (CRC) will be progressing directly into Phase III at 20mg. Patients will also continue to be recruited at 20mg into the first line CRC HORIZON II study of RECENTIN with chemotherapy versus chemotherapy alone.
|
|
22 February 2008
AstraZeneca To Appeal Judgment In Alabama Medical Pricing Case |
AstraZeneca today announced it intends to seek reconsideration or reversal of a verdict in the Montgomery County Circuit Court awarding $40 million in compensatory damages and $175 million in punitive damages for alleged false and misleading reporting of prices for drugs reimbursed by the Alabama State Medicaid Agency in the US.
|
|
18 February 2008
AstraZeneca PLC appoints new Non-Executive Director |
AstraZeneca today announced that Jean-Philippe Courtois is to join the Board of Directors as a Non-Executive Director with immediate effect. Jean-Philippe Courtois is currently President of Microsoft International, a territory that spans 100 subsidiaries operating in over 240 countries outside the United States and Canada, and a Senior Vice-President of Microsoft Corporation.
|
|
14 February 2008
AstraZeneca and Nomura Phase4 Ventures Announce Creation of New Company “Albireo” |
AstraZeneca and Nomura Phase4 Ventures today announced the signing of a deal to form Albireo, a company focused on developing new treatments for gastrointestinal (GI) disorders.
|
|
11 February 2008
AstraZeneca Submits Seroquel XR™ in Europe for the Treatment of Bipolar Mania and Bipolar Depression and Seroquel® for Treatment of Bipolar Depression |
AstraZeneca today announced that the company has submitted applications in the European Union (EU) under the Mutual Recognition Procedure (MRP) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, seeking approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder. This follows two supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA), announced in January, for the same indications.
|
|
4 February 2008
AstraZeneca Biologics Division, MedImmune, Submits Biologics License Application to FDA for motavizumab |
AstraZeneca PLC announced today that its biologics division, MedImmune, had submitted a Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology.
|
|
31 January 2008
Fourth Quarter and Full Year Results 2007 |
“Earnings per share for the full year ahead of target. With the addition of six new molecules to the late stage pipeline during 2007, there are now 10 projects in Phase III development.”
|
|
21 January 2008
AstraZeneca Becomes Major Sponsor of Shanghai Expo UK Pavilion |
AstraZeneca China has agreed to become a major sponsor of the UK Pavilion at Shanghai Expo 2010. AstraZeneca’s sponsorship will amount to £500,000 and will directly support the design, development and staging of the British pavilion.
|
|
15 January 2008
First Head to Head Study Comparing CRESTOR™ and LIPITOR® Effects on the Treatment of Atherosclerosis |
AstraZeneca today announced the launch of a new clinical trial, SATURN, designed to measure the impact of CRESTOR™ (rosuvastatin) 40 mg and atorvastatin (Lipitor®) 80 mg on the progression of atherosclerosis in high risk patients. SATURN will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease.
|
|
2 January 2008
AstraZeneca Submits sNDAs for Seroquel XR™ for the Treatment of Bipolar Mania and Bipolar Depression |
AstraZeneca today announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.
|
|