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AstraZeneca
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AstraZeneca is one of the world's leading pharmaceutical companies, our business is focused on turning good ideas into innovative, effective medicines that make a real difference in important areas of healthcare. This RSS feed contains press releases and investor news.
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AstraZeneca and Bristol-Myers Squibb Submit New Drug Application in the United States and Marketing Authorisation Application in Europe for ONGLYZA? (Saxagliptin) for the Treatment of Type 2 Diabetes
AstraZeneca and Bristol-Myers Squibb Company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA? (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by AstraZeneca and Bristol-Myers Squibb for the treatment of type 2 diabetes. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
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Summary Judgment Granted for SEROQUEL Patent Litigation in the US
AstraZeneca today announced that the US District Court for the District of New Jersey has granted the company's Motion for Summary Judgment of No Inequitable Conduct. AstraZeneca had sued 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 sought approval to market generic versions of SEROQUEL (quetiapine fumarate) tablets in the US before SEROQUEL's patent expires in 2011. Since the Court granted AstraZeneca's motion for Summary Judgment of No Inequitable Conduct in its entirety, trial is unnecessary.
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AstraZeneca Announces Senior Management Changes at Biologics Business Unit, MedImmune
AstraZeneca today announced that Dave Mott, President and Chief Executive Officer (CEO) of its biologics business unit, MedImmune, has decided to leave the company at the end of July. Tony Zook, CEO of AstraZeneca?s North American business and Executive Vice President of Global Marketing, has been appointed as head of MedImmune on an interim basis until a permanent successor is identified.
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AstraZeneca and Columbia University Medical Center Sign Strategic Research Collaboration to Develop Novel Therapeutics for Diabetes and Obesity
AstraZeneca and Columbia University Medical Center in New York today announced that they have entered into a strategic research collaboration in metabolic related diseases, to develop novel therapeutics primarily in type 2 diabetes and obesity and, with a secondary focus on atherosclerosis (hardening of the arteries)/dyslipidaemia (abnormal blood lipid levels).
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AstraZeneca Submits Seroquel XR? in Europe for the Treatment of Major Depressive Disorder
AstraZeneca today announced that the company has submitted applications in the European Union (EU) for once-daily SEROQUEL XR? (quetiapine fumarate) Extended-Release Tablets (quetiapine XR), seeking approval for the treatment of major depressive disorder (MDD) including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP). This follows a supplementary New Drug Application (sNDA) submission for SEROQUEL XR in MDD in the U.S. in February this year.
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AstraZeneca Submits an sNDA for SYMBICORT® for the Treatment of Asthma in Children as Young as Age Six
AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in paediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
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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.
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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.
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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.
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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.
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