Press release archive 2009

Thursday, 24 December 2009
MedImmune Replies to FDA Complete Response Letter on Motavizumab AstraZeneca today announced that MedImmune, its biologics unit, has filed its formal regulatory reply to a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). MedImmune received the CRL asking for additional information regarding motavizumab on 25 November 2008, and the company has been in ongoing discussions with FDA reviewers since then to complete and file its CRL reply.
Wednesday, 23 December 2009
AstraZeneca To Acquire Infection Research Company Novexel And Expand Collaboration With Forest Laboratories AstraZeneca announced today that it has entered into an agreement to acquire Novexel and will collaborate with Forest Laboratories on the future co-development and commercialization of two late-stage antibiotic development programmes.
Tuesday, 15 December 2009
Favourable Vote From FDA Advisory Committee On Benefit/Risk Of CRESTOR In JUPITER Study Favourable Vote From FDA Advisory Committee On Benefit/Risk Of CRESTOR In JUPITER Study
Friday, 11 December 2009
Advisory Committee Briefing Materials For Crestor sNDA Available On US FDA Web Site The U.S. Food and Drug Administration (FDA) today posted briefing materials in advance of 15 December 2009 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the supplemental New Drug Application (sNDA) filed by AstraZeneca. The briefing materials can be found on the FDA web site.
Friday, 4 December 2009
US FDA Approves Seroquel For The Paediatric Treatment Of Schizophrenia And Bipolar Mania AstraZeneca today announced that the US Food and Drug Administration (FDA) approved SEROQUEL (quetiapine fumarate) Tablets for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.
Friday, 4 December 2009
US FDA Approves Seroquel XR For Add-On Treatment Of Major Depressive Disorder AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).  SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy.
Thursday, 3 December 2009
AstraZeneca and Targacept Form Global Collaboration and Licence Agreement for Late-Stage Investigational Product TC-5214 for the Treatment of Major Depressive Disorder AstraZeneca and Targacept, Inc. today announced a collaboration and licence agreement for the global development and commercialisation of TC-5214, Targacept’s late-stage investigational product for major depressive disorder (MDD). TC-5214, which recently completed a phase IIb clinical trial, is a nicotinic channel blocker that is thought to treat depression by modulating the activity of various neuronal nicotinic receptor (NNR) subtypes.
Thursday, 19 November 2009
AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor), an Investigational Antiplatelet Agent AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
Wednesday, 18 November 2009
Results from Two Phase II Trials Add to Understanding of Brilinta (Ticagrelor) and How it Works in the Body AstraZeneca today announced the results of the phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (BRILINTA) at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL, with ONSET/OFFSET study results being simultaneously published in the medical journal Circulation.
Monday, 16 November 2009
BRILINTA Demonstrated Greater Efficacy Over Clopidogrel in the Most Urgent Clinical Setting: Patients with ST-Segment Elevation Myocardial Infarction and Planned Percutaneous Coronary Intervention (PCI) AstraZeneca today announced results of a PLATO sub-analysis in the most serious type of Acute Coronary Syndrome (ACS) patients, those with ST Segment Elevation Myocardial Infarction (STEMI). In this setting, ST segment elevation indicates total obstruction of a coronary artery which warrants emergency surgery with angioplasty, a procedure termed primary Percutaneous Coronary Intervention or “PCI,” in order to restore flow, salvage the heart muscle (myocardium) from infarction and reduce mortality.