These press releases are for business and financial media.
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- 14 December 2007
- ARIMIDEX Significantly Superior to Tamoxifen in Reducing Risk Of Breast Cancer Returning and Increasing Disease-Free Survival Landmark results from one of the world’s largest breast cancer trials, presented today at the San Antonio Breast Cancer Symposium (SABCS) USA, and published online in The Lancet Oncology, reinforce that ARIMIDEX (anastrozole) is significantly superior to tamoxifen in reducing the risk of breast cancer returning and in increasing disease-free survival (DFS) in postmenopausal women with hormone receptor positive (HR+) early disease.
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- 12 December 2007
- AstraZeneca Files Patent Infringement Actions in Response to Crestor™ ANDAs AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™
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- 10 December 2007
- FDA Concludes There Is No Increased Risk Of Cardiac Events For Patients Treated With Omeprazole And NEXIUM® (Esomeprazole Magnesium) The US Food and Drug Administration (FDA) today issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM ® (LOTUS study) treatment.
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- 07 December 2007
- AstraZeneca Presents its Global Biologics Organisation, MedImmune, at 2007 Analyst and Investor R&D Day AstraZeneca (AZN) today holds an R&D day for analysts and investors at the headquarters of its global biologics organisation, MedImmune, in Gaithersburg, Maryland, USA, to present its recently expanded world-class biologics expertise. At the meeting, which will run from 9:00 AM to 3:00 PM EST, senior leaders from MedImmune will present the Company’s highly developed capabilities in antibody and vaccine discovery, development, production and commercialisation within the broader context of AstraZeneca’s R&D
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- 29 November 2007
- AstraZeneca Receives Six Months Paediatric Exclusivity Patent Extension For ARIMIDEX® From The FDA AstraZeneca today announced that the United States (US) Food and Drug Administration (FDA) has granted an additional six month period of exclusivity to market ARIMIDEX® (anastrozole) for its licensed breast cancer indications until June 2010. Prior to paediatric exclusivity being granted by the FDA, the patent was due to expire in December 2009.
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- 19 November 2007
- EPO Rules AstraZeneca MUPS® Patent Valid The European Patent Office (EPO) Opposition Division today ruled that the European patent for a MUPS ® formulation (EP 723 437) is still valid in amended form, despite four oppositions from generic drug manufacturers.
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- 16 November 2007
- Seroquel XR™ Receives Approval from FDA for Maintenance Treatment of Schizophrenia AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients. On May 17, 2007, the FDA approved SEROQUEL XR for the acute treatment of schizophrenia in adult patients.
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- 09 November 2007
- CRESTOR® Now Indicated To Slow The Progression Of Atherosclerosis In Patients With Elevated Cholesterol AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved CRESTOR® (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. This new indication gives CRESTOR an important differentiator from competitors in the cholesterol-lowering marketplace.
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- 07 November 2007
- AstraZeneca launches and prices a debut GBP 350 million sterling bond and a EUR 750 million eurobond AstraZeneca PLC, rated A1 (stable) by Moody's and AA- (stable) by Standard & Poor's, announces the successful pricing of a debut sterling bond for GBP 350 million and a Euro 750 million eurobond transaction (the “Bonds”). The proceeds of the issue will be used for general corporate purposes and to repay a portion of the outstanding US commercial paper taken on in connection with the acquisition of MedImmune.
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- 05 November 2007
- New Data Examines The Effect Of Adding A Statin To Optimised Treatment For Patients With Advanced Heart Failure New data from the CORONA study presented today at the American Heart Association 2007 Scientific Sessions in Orlando, US, showed that adding a statin to optimised heart failure treatment did not significantly improve the prognosis for patients with advanced heart failure because it could not reverse or prevent the deterioration of a failing heart.
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- 01 November 2007
- Third Quarter and Nine Months Results 2007 AstraZeneca PLC Third Quarter and Nine Months Results 2007
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- 01 November 2007
- CRESTOR™ ANDA On 30th October 2007, AstraZeneca received a notice-letter from Cobalt Pharmaceuticals, Inc. (“Cobalt”) notifying AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha that Cobalt had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market generic rosuvastatin calcium tablets. Cobalt’s notice-letter advised that it intended to market generic versions of Crestor™ tablets in 5, 10, 20, and
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- 18 October 2007
- EPO Announces Symbicort® European Combination 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 for Symbicort ® (formoterol and budesonide) (EPB0613371) has been revoked, following an appeal from a group of generic manufacturers: Liconsa, Miat, Generics UK and Norton Healthcare; but parties to the proceedings are also the additional opponents (Chiesi Farmaceutici SpA, Zambon Group SpA, Yamanouchi Europe B.V.).
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- 09 October 2007
- EPO Rules European Nexium® Process Patent Valid AstraZeneca today announced that the European Patent Office (EPO) Opposition Division has ruled that the European process patent EP 0773940 for Nexium ® is valid in amended form, despite an opposition by the German generic manufacturer ratiopharm. The patent has been upheld as granted with regards to claims 1 and 2. Regarding claims 3 and 4, minor amendments have been made.
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- 28 September 2007
- AstraZeneca Appoints Chief Financial Officer AstraZeneca PLC has today announced the appointment of Simon Lowth as an Executive Director and Chief Financial Officer with effect from November 5, 2007. In this role he will be responsible for Finance and Information Services.
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- 26 September 2007
- AstraZeneca Signs Master Clinical Study Agreement with Keio University To Counteract ‘Drug Lag’ Keio University School of Medicine, based in Shinjuku-ku, Tokyo, and AstraZeneca K.K., the Osaka-based subsidiary of AstraZeneca, today announced a Master Clinical Study Agreement. Separate project agreements on future clinical trials involving the two parties will be concluded independently under this master agreement.
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- 19 September 2007
- FDA Approves Expanded Label For FluMist® To Include Children Two To Five Years Of Age GAITHERSBURG, MD, September 19, 2007 – MedImmune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist® (Influenza Virus Vaccine Live, Intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children
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- 13 September 2007
- AstraZeneca launches and prices a EUR750 million debut eurobond AstraZeneca PLC, rated A1 (stable) by Moody's and AA- (stable) by Standard & Poor's, yesterday priced a successful debut eurobond transaction (the “Bonds”) issuing a total of EUR750 million. The proceeds of the issue will be used for general corporate purposes and to repay a portion of the outstanding US commercial paper taken on in connection with the acquisition of MedImmune.
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- 07 September 2007
- AstraZeneca and Pozen To Start Phase III Trials With PN400 AstraZeneca announced today that it will start a Phase III programme for PN400, a new pain product under co-development with POZEN, Inc. The Phase III programme is scheduled to begin in 3Q 2007, with a US submission currently targeted for 1H 2009.
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- 06 September 2007
- AstraZeneca launches and prices a $6.9 billion bond issue AstraZeneca PLC, rated A1 (stable) by Moody’s and AA- (stable) by Standard & Poor’s, yesterday announced a successful global bond market transaction issuing a total of $6.9 billion. The proceeds of the issue will be used to repay a significant portion of the outstanding US commercial paper taken on in connection with the acquisition of MedImmune.
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- 05 September 2007
- Study Shows IRESSA™ (Gefitinib) Is As Effective As Docetaxel In Pre-Treated Advanced NSCLC Data presented today at the World Conference on Lung Cancer in Korea by Professor Jean-Yves Douillard, Centre Rene Gauducheau, France, Principal Investigator of the INTEREST study, show that patients with non-small cell lung cancer (NSCLC) treated with the oral anti-cancer drug IRESSA (gefitinib) had equivalent (non-inferior) survival to those treated with intravenous docetaxel. In addition, IRESSA demonstrated a more favourable tolerability profile and superior quality of life for patients versus
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- 04 September 2007
- AstraZeneca Enhances Clinical Research Capabilities in China With First Clinical Pharmacology Unit AstraZeneca today announced a strategic partnership with Peking University 3rd Hospital to open its first Clinical Pharmacology Unit (CPU) in China. The unit aims to enhance local clinical research capabilities and speed up access to new medicines to benefit Chinese patients.
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- 31 August 2007
- AstraZeneca and Abbott Announce Selection of Next-Generation Fenofibrate (ABT-335) and CRESTOR® Fixed-Dose Combination AstraZeneca and Abbott confirmed today they will advance the development of Abbott's next-generation fenofibrate (ABT-335) and AstraZeneca's CRESTOR® (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials. The single pill would target all three major blood lipids – LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
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- 29 August 2007
- AstraZeneca’s Once-Daily SEROQUEL XR™ Extended-Release Tablets Approved in Netherlands For The Acute and Long Term Treatment Of Schizophrenia AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. With SEROQUEL XR™ patients can achieve a dose within the recommended range as early as the second day of treatment and the MEB approval also includes relapse prevention in the long-term treatment of schizophrenia. AstraZeneca will proceed with a Mutual
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- 26 July 2007
- Second Quarter and Half Year Results 2007 AstraZeneca PLC - Second Quarter and Half Year Results 2007
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- 25 July 2007
- AstraZeneca PLC appoints new Non-Executive Director AstraZeneca today announced that Bo Angelin is to join the Board of Directors as a Non-Executive Director with immediate effect. Bo Angelin is currently Professor of Clinical Metabolism at Karolinska Institutet and Head of the Department of Endocrinology, Metabolism and Diabetes at the Karolinska University Hospital in Stockholm, Sweden, where his research group is studying the regulation of lipid metabolism in the liver by genes, diets, and hormones in order to find new ways of eliminating cholesterol from
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- 26 June 2007
- First Phase II Short-term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects with Type 2 Diabetes In a 14-day, Phase IIa study of the safety profile of multiple doses of the investigational compound dapagliflozin, a selective inhibitor of the Sodium-Glucose Transporter 2 (SGLT2) administered alone or concomitantly with metformin in subjects with Type 2 diabetes, no discontinuations due to adverse events and no serious adverse events were reported. The study, presented this week at the annual meeting of the American Diabetes Association, also reported that dapagliflozin, in development by Bristol-Myers
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- 26 June 2007
- Data Demonstrated Saxagliptin Added to Metformin Improved Glycemic Control in Subjects with Type 2 Diabetes Compared to Metformin Alone Phase III data presented this week at the annual meeting of the American Diabetes Association demonstrated that saxagliptin, an inhibitor of dipeptidyl-peptidase-4 (DPP-4) in development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), in combination with metformin, exhibited a statistically significant improvement in glycemic control in subjects with Type 2 diabetes compared to metformin alone through 24 weeks of treatment. This was the first time that Phase III data for saxagliptin
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- 25 June 2007
- AstraZeneca Announces Symbicort® Is Now Available In The U.S. AstraZeneca today announced that SYMBICORT® (budesonide/formoterol) pressurised Metered Dose Inhaler (pMDI) is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.
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