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23 July 2008
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.
|  | 2 July 2008
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.
| | 26 June 2008
AstraZeneca Announces Senior Management Changes at Biologics Business Unit, MedImmune | Dave Mott to leave AstraZeneca, Tony Zook takes over as interim head of 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.
| | 17 June 2008
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).
| | 10 June 2008
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.
| | 4 June 2008
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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