http://www.astrazeneca.com:80/media/latest-press-releases/2009/ Subscribe to AstraZeneca news via RSS en en http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7904328&user_locale=en 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. Thu, 24 Dec 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7904328&user_locale=en 2009-12-24T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7903556&user_locale=en 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. Wed, 23 Dec 2009 15:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7903556&user_locale=en 2009-12-23T15:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7814793&user_locale=en Favourable Vote From FDA Advisory Committee On Benefit/Risk Of CRESTOR In JUPITER Study Tue, 15 Dec 2009 22:10:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7814793&user_locale=en 2009-12-15T22:10:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7765520&user_locale=en 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. Fri, 11 Dec 2009 16:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7765520&user_locale=en 2009-12-11T16:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7660757&user_locale=en 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. Fri, 04 Dec 2009 07:00:02 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7660757&user_locale=en 2009-12-04T07:00:02Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7660753&user_locale=en 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. Fri, 04 Dec 2009 07:00:01 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7660753&user_locale=en 2009-12-04T07:00:01Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7647233&user_locale=en 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. Thu, 03 Dec 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7647233&user_locale=en 2009-12-03T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7501665&user_locale=en 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. Thu, 19 Nov 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7501665&user_locale=en 2009-11-19T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7499699&user_locale=en 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. Wed, 18 Nov 2009 14:15:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7499699&user_locale=en 2009-11-18T14:15:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7476684&user_locale=en 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. Mon, 16 Nov 2009 01:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7476684&user_locale=en 2009-11-16T01:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7457581&user_locale=en AstraZeneca announced today that Jan M. Lundberg, Executive Vice President, Discovery Research has resigned to pursue other interests outside the company. Jan will step down from his operational role with immediate effect. Fri, 13 Nov 2009 14:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7457581&user_locale=en 2009-11-13T14:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7326482&user_locale=en Strong business performance has been driven by good operating execution bolstered by revenue upsides from Toprol-XL and H1N1 vaccine sales. Core EPS target for the year has been increased and progress has been made on the pipeline with the approval of ONGLYZA(TM), the European submission for Brilinta and new external collaborations, tempered by the disappointing news on Zactima. Thu, 29 Oct 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7326482&user_locale=en 2009-10-29T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7317146&user_locale=en AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009. Wed, 28 Oct 2009 01:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7317146&user_locale=en 2009-10-28T01:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7234277&user_locale=en AstraZeneca and POZEN Inc. today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA. Mon, 19 Oct 2009 08:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7234277&user_locale=en 2009-10-19T08:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7207730&user_locale=en AstraZeneca and POZEN, Inc. today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO. Fri, 16 Oct 2009 08:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7207730&user_locale=en 2009-10-16T08:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7206200&user_locale=en AstraZeneca today announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary. Fri, 16 Oct 2009 07:56:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7206200&user_locale=en 2009-10-16T07:56:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7206113&user_locale=en AstraZeneca today announced the US Food and Drug Administration (FDA) approved CRESTOR (rosuvastatin calcium) for use in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the “bad” cholesterol) and increased risk of early cardiovascular disease. Fri, 16 Oct 2009 07:55:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7206113&user_locale=en 2009-10-16T07:55:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7129649&user_locale=en AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for ONGLYZA (saxagliptin) in the 27 countries of the European Union. Mon, 05 Oct 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7129649&user_locale=en 2009-10-05T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7129849&user_locale=en Results from an 18-week phase IIIb study in adults with type 2 diabetes with inadequate glycemic control on metformin therapy alone found that the addition of treatment with ONGLYZA (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA (sitagliptin) 100 mg per day in reducing HbA1c from baseline. Mon, 05 Oct 2009 06:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7129849&user_locale=en 2009-10-05T06:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7108139&user_locale=en Results from a 24-week phase 3 clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin. Fri, 02 Oct 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7108139&user_locale=en 2009-10-02T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7082393&user_locale=en AstraZeneca announced today that once-daily SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. Tue, 29 Sep 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7082393&user_locale=en 2009-09-29T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7063159&user_locale=en AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving SEROQUEL (quetiapine fumarate) tablets. Fri, 25 Sep 2009 08:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7063159&user_locale=en 2009-09-25T08:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7030566&user_locale=en New data from the phase III PLATO study showed that BRILINTA (ticagrelor) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%, p=0.0025 a 16% Relative Risk Reduction) in acute coronary syndromes patients undergoing planned invasive treatment (either PCI or CABG). Patients with planned invasive procedures at randomisation accounted for more than 70% of the greater than 18,000 patients in PLATO. Fri, 25 Sep 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7030566&user_locale=en 2009-09-25T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7030560&user_locale=en AstraZeneca and Nektar Therapeutics announced today that they have entered into an exclusive worldwide license agreement for two drug development programmes. Mon, 21 Sep 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=7030560&user_locale=en 2009-09-21T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6888076&user_locale=en AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted on 30 June 2009 by its development partner, POZEN, Inc., for VIMOVO (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN400) tablets. Mon, 31 Aug 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6888076&user_locale=en 2009-08-31T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6868332&user_locale=en AstraZeneca today announced results from the phase III head to head trial, PLATO. Sun, 30 Aug 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6868332&user_locale=en 2009-08-30T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6727451&user_locale=en AstraZeneca and Forest Laboratories announced today they have entered into a definitive collaboration agreement to co-develop and commercialise ceftaroline in all markets outside the United States, Canada and Japan. Ceftaroline is Forest’s late stage, next generation cephalosporin being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). Wed, 12 Aug 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6727451&user_locale=en 2009-08-12T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6649101&user_locale=en AstraZeneca and Astellas Pharma Inc. today announced an agreement for the co-promotion of AstraZeneca’s Symbicort Turbuhaler (budesonide/ formoterol, a dry powder inhaler), for the treatment of bronchial asthma in Japan. Tue, 04 Aug 2009 05:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6649101&user_locale=en 2009-08-04T05:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6626448&user_locale=en AstraZeneca and Bristol-Myers Squibb today announced that the US Food and Drug Administration (FDA) has approved ONGLYZA (saxagliptin) for the treatment of type 2 diabetes mellitus in adults. Fri, 31 Jul 2009 23:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6626448&user_locale=en 2009-07-31T23:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6598224&user_locale=en AstraZeneca’s business performance, in the context of tough global economic conditions, has been better than anticipated. The strong first half performance is reflected in the increased Core EPS target for the full year and continued progress has been made on the pipeline. Thu, 30 Jul 2009 06:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6598224&user_locale=en 2009-07-30T06:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6425941&user_locale=en AstraZeneca announced today that it has terminated the license agreement with MAP Pharmaceuticals, Inc., regarding Unit Dose Budesonide (UDB). Thu, 09 Jul 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6425941&user_locale=en 2009-07-09T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6416165&user_locale=en AstraZeneca plans to conduct further development of AZD3480 by initiating Phase IIb studies in attention deficit/hyperactivity disorder (ADHD) and has agreed to make a $10 million milestone payment to Targacept. Wed, 08 Jul 2009 13:15:26 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6416165&user_locale=en 2009-07-08T13:15:26Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6346156&user_locale=en AstraZeneca announced today that the European Commission has granted marketing authorisation for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy. Wed, 01 Jul 2009 05:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6346156&user_locale=en 2009-07-01T05:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6343229&user_locale=en AstraZeneca today announced that its development partner, Pozen, Inc., has submitted a New Drug Application to the US Food and Drug Administration for VIMOVO (PN400) (enteric coated naproxen /esomeprazole magnesium) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing NSAID-associated ulcers. Tue, 30 Jun 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6343229&user_locale=en 2009-06-30T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6297230&user_locale=en AstraZeneca and Bristol-Myers Squibb Company today announced that their marketing authorisation application for ONGLYZA (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea. Thu, 25 Jun 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6297230&user_locale=en 2009-06-25T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6165712&user_locale=en On 10 June 2009, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a review of the efficacy and safety of supplemental new drug applications (sNDAs) for SEROQUEL (quetiapine fumarate) proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age). Wed, 10 Jun 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6165712&user_locale=en 2009-06-10T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6084714&user_locale=en AstraZeneca and Abbott announced today that the companies have submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL cholesterol (the “bad” cholesterol), high triglycerides and low HDL-cholesterol (the “good” cholesterol). Thu, 04 Jun 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6084714&user_locale=en 2009-06-04T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6084746&user_locale=en AstraZeneca and Abbott announced today that they have entered into an agreement for AstraZeneca to co-promote Abbott’s TRILIPIX, a medication for use alone or in combination with a statin to treat certain lipid disorders. Thu, 04 Jun 2009 06:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6084746&user_locale=en 2009-06-04T06:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6043833&user_locale=en AstraZeneca and Merck & Co., Inc. today announced a collaboration to research a novel combination anticancer regimen composed of two investigational compounds, MK-2206 from Merck and AZD6244 from AstraZeneca. Mon, 01 Jun 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6043833&user_locale=en 2009-06-01T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6016554&user_locale=en AstraZeneca today announced that the company has referred its application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of recurrent depressive episodes in adult patients with major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use (CHMP; a scientific committee of the European Medicines Agency, EMEA). Fri, 29 May 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=6016554&user_locale=en 2009-05-29T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5885968&user_locale=en On 20 May 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for an injunction barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES (budesonide inhalation suspension) in the US. No trial date for the patent litigation has been set. Wed, 20 May 2009 05:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5885968&user_locale=en 2009-05-20T05:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5837126&user_locale=en AstraZeneca today announced top line results from the phase III trial, PLATO, which demonstrate that BRILINTA, the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS. Mon, 11 May 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5837126&user_locale=en 2009-05-11T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5717149&user_locale=en AstraZeneca has proved to be resilient in the first quarter of 2009, the result of excellent execution in driving growth in key product franchises and in all regions, whilst delivering improvements in operating efficiency. Thu, 30 Apr 2009 10:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5717149&user_locale=en 2009-04-30T10:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5585247&user_locale=en AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval of the targeted oral anti-cancer drug, IRESSA (gefitinib). Thu, 23 Apr 2009 10:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5585247&user_locale=en 2009-04-23T10:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5582237&user_locale=en AstraZeneca and Bristol-Myers Squibb reported today that the US Food and Drug Administration (FDA) has determined it needs additional time to complete the review of the New Drug Application (NDA) for ONGLYZA (saxagliptin) for the treatment of type 2 diabetes. Thu, 23 Apr 2009 09:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5582237&user_locale=en 2009-04-23T09:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5453714&user_locale=en On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for a temporary restraining order, barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES until further order of the court. Fri, 17 Apr 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5453714&user_locale=en 2009-04-17T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5308259&user_locale=en On 8 April 2009, the U.S. Food and Drug Administration Psychopharmacologic Drugs Advisory Committee conducted a review of the safety and efficacy of supplemental new drug applications for SEROQUEL XR extended-release tablets proposed for the treatment of major depressive disorder and generalised anxiety disorder. Thu, 09 Apr 2009 03:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5308259&user_locale=en 2009-04-09T03:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5287486&user_locale=en AstraZeneca has filed a lawsuit in the US District Court for the District of New Jersey against Apotex seeking a declaration of patent infringement. Tue, 07 Apr 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5287486&user_locale=en 2009-04-07T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5278217&user_locale=en AstraZeneca today announced the company has received a Complete Response Letter from the US Food and Drug Administration for SYMBICORT pressurized metered dose inhaler for the long-term maintenance treatment of asthma in pediatric patients ages 6-11 years. Mon, 06 Apr 2009 04:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5278217&user_locale=en 2009-04-06T04:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5278211&user_locale=en AstraZeneca today announced that the Competition Authority in Sweden has approved the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products. Mon, 06 Apr 2009 02:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5278211&user_locale=en 2009-04-06T02:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5282463&user_locale=en PhRMA Annual Meeting Fri, 03 Apr 2009 07:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5282463&user_locale=en 2009-04-03T07:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5227203&user_locale=en AstraZeneca and Bristol-Myers Squibb today announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZA (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the programme. Thu, 02 Apr 2009 03:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5227203&user_locale=en 2009-04-02T03:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5199467&user_locale=en AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 9 and 10 June 2009. Mon, 30 Mar 2009 03:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5199467&user_locale=en 2009-03-30T03:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4978104&user_locale=en AstraZeneca has today published its Annual Report and Form 20-F Information 2008. Wed, 04 Mar 2009 15:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4978104&user_locale=en 2009-03-04T15:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4956283&user_locale=en AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Mon, 02 Mar 2009 06:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4956283&user_locale=en 2009-03-02T06:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4936615&user_locale=en AstraZeneca today announced that Håkan Mogren, Non-Executive Deputy Chairman of AstraZeneca PLC, will retire from the Board at the close of the company’s AGM on 30 April 2009. Fri, 27 Feb 2009 09:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4936615&user_locale=en 2009-02-27T09:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5181169&user_locale=en AstraZeneca today announced the company has received a Complete Response Letter from the U.S. Food and Drug Administration asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Generalised Anxiety Disorder in adult patients. Fri, 27 Feb 2009 01:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=5181169&user_locale=en 2009-02-27T01:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4925932&user_locale=en AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 8 April 2009. AstraZeneca has been advised that at its meeting, the PDAC will discuss the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR proposed for the treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD). Wed, 25 Feb 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4925932&user_locale=en 2009-02-25T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4915105&user_locale=en MAP Pharmaceuticals, Inc. announced yesterday that its initial Phase III clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in night-time and daytime composite symptom scores, in either of the doses evaluated when compared with placebo. Tue, 24 Feb 2009 00:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4915105&user_locale=en 2009-02-24T00:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4759388&user_locale=en AstraZeneca has delivered a robust performance in an increasingly challenging market environment. Good headway is being made in further improving the efficiency of the organization, and the expansion in the scope of our restructuring efforts is another important step towards sustaining long-term competitiveness. Thu, 29 Jan 2009 11:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4759388&user_locale=en 2009-01-29T11:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4569754&user_locale=en POZEN Inc., AstraZeneca’s co-development partner for the investigational compound PN 400, has been informed that the US Food and Drug Administration (FDA) has completed its internal discussions and that there is no change to the previous agreements that gastric ulcer incidence is an acceptable primary endpoint for the PN 400 Phase III clinical programmes. Thu, 29 Jan 2009 08:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4569754&user_locale=en 2009-01-29T08:00:00Z http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4560400&user_locale=en MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza. Tue, 06 Jan 2009 08:00:00 GMT http://www.astrazeneca.com:80/media/latest-press-releases/2009/?itemId=4560400&user_locale=en 2009-01-06T08:00:00Z