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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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7 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 activities.
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5 December 2007
AstraZeneca Presents New Depression and Anxiety Results for SEROQUEL XR™ |
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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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9 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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7 November 2007
AstraZeneca launches and prices a debut GBP 350 million sterling bond and a EUR 750 million eurobond |
Not for release, publication or distribution directly or indirectly in or into the United States, Canada, Australia or Japan
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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5 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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1 November 2007
Third Quarter and Nine Months Results 2007 |
“Nine Months sales up 7 percent, core EPS up 8 percent. On track to deliver full year earnings target.”
AstraZeneca PLC Third Quarter and Nine Months Results 2007
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1 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 40 mg strengths before the expiration of US Patents Nos. RE37,314E (the ‘314 patent) and 6,316,460B1 (the ‘460 patent). Cobalt’s notice-letter states that its ANDA contained a Paragraph IV certification alleging that the claims of the ‘314 and ‘460 patents are not infringed, invalid or unenforceable. Cobalt’s notice-letter also states that its ANDA contains a certification under section 505(j)(2)(A)(viii) of the FDCA alleging that its labelling will not include medical uses claimed in US Patent 6,858,618 (the ‘618 patent).
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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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9 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 |
First and Only Nasal Spray Influenza Vaccine for Young Children in U.S. Available for 2007-2008 Flu Season
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 under four years of age.
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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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7 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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6 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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5 September 2007
Study Shows IRESSA™ (Gefitinib) Is As Effective As Docetaxel In Pre-Treated Advanced NSCLC |
Largest Phase III study ever reported comparing two active treatments in patients with 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 docetaxel.
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4 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 |
First Statin and Fibrate Combination in a Single Pill To Target Major Lipid Components moves forward to next phase of development
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 Recognition Procedure, seeking similar approvals across Europe. SEROQUEL XR™ was approved for the treatment of schizophrenia in the US in May 2007.
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26 July 2007
Second Quarter and Half Year Results 2007 |
“Solid financial performance in the First Half. Pipeline strengthened with two new compounds progressing to Phase III development and the addition of MedImmune.”
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 the body.
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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 |
Additional Findings Reported on Glucose Homeostasis Effects
in Normal and Diabetic Rats
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 Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), statistically significantly reduced fasting serum glucose (FSG) and post challenge glucose excursion in subjects with Type 2 diabetes.
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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 |
Additional Findings Reported Safety & Tolerability Profile in Subjects with Type 2 Diabetes and Healthy Subjects
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 have been presented in a scientific setting.
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25 June 2007
AstraZeneca Announces Symbicort® Is Now Available In The U.S. |
U.S. Asthma Sufferers Now Have a New Choice of Combination Therapy to Help Achieve Asthma Control
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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19 June 2007
AstraZeneca Successfully Completes Acquisition of MedImmune |
View full press release
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6 June 2007
AstraZeneca Successfully Completes Tender Offer for MedImmune Shares |
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6 June 2007
AstraZeneca CFO to join Goldman Sachs |
AstraZeneca PLC announces the resignation of its Chief Financial Officer, Jon Symonds, with effect from the end of July. Jon Symonds joined Zeneca in 1997 as CFO after 17 years at KPMG. Within months of joining, he was involved in the merger negotiations with Swedish pharmaceutical company, Astra. After completion of the merger in 1999, Jon was appointed as CFO for AstraZeneca PLC.
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4 June 2007
AstraZeneca Acquires Biologics Manufacturing Facility in Canada |
AstraZeneca today announced that it has acquired a biologics manufacturing facility in Montreal, Canada, from DSM Biologics Inc. The facility, occupying 66,000 sq. ft, will be used to manufacture antibody drug candidates for clinical trials and will serve the whole of the AstraZeneca group.
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1 June 2007
AstraZeneca’s Prilosec® Patents Upheld By Court |
Patent Infringement Suit Won Against Impax And Apotex
In Second Wave Prilosec® Trial
AstraZeneca today announced a ruling by the US District Court for the Southern District of New York that found two Prilosec® (omeprazole) formulation patents valid and infringed by Impax Laboratories Inc. and Apotex Corp.
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1 June 2007
Successful AstraZeneca Tender Offer for MedImmune Shares |
96.0% of MedImmune’s Shares Tendered and Subsequent Offering Period Announced
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18 May 2007
FDA Approves AstraZeneca’s Once-Daily SEROQUEL XR™ Extended-Release Tablets For The Treatment Of Schizophrenia |
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The SEROQUEL XR development programme was based on the needs of patients and physicians for a wider choice of medicines that offer convenient once-daily dosing. With SEROQUEL XR patients can achieve a dose within the recommended range as early as the second day of treatment.
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3 May 2007
Recommended Cash Tender Offer for MedImmune by AstraZeneca |
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23 April 2007
AstraZeneca's fully recommended cash offer for MedImmune, Inc. |
View full press release
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23 April 2007
First quarter results 2007 |
“First quarter sales up 9 percent and Earnings per Share up 14 percent. On
track to achieve full year financial targets.”
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23 April 2007
AstraZeneca announces decision to discontinue collaboration with AtheroGenics regarding AGI-1067 |
AstraZeneca today announced that it has decided to terminate the License and Collaboration Agreement with AtheroGenics, Inc. (Nasdaq: AGIX), regarding AGI-1067.
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20 April 2007
Senior Management Changes At AstraZeneca |
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17 April 2007
Alistair Darling MP, Secretary of State for Trade and Industry, Celebrates ‘Golden Age’ of Science and Innovation at AstraZeneca’s Alderley Park Site |
Alistair Darling MP, Secretary of State for Trade and Industry, today visited AstraZeneca in Cheshire to launch the official celebration of Alderley Park’s 50th Anniversary.
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25 March 2007
First Study To Show Positive Benefit On Atherosclerosis For People With Early Signs Of Diseased Arteries |
METEOR Trial Shows CRESTOR Slowed Progression Of Atherosclerosis In People At Low-Risk* Of Coronary Heart Disease
AstraZeneca today announced that the METEOR clinical trial of CRESTOR is the first study to show a positive effect on atherosclerosis in people with early signs of carotid artery disease and at low risk of coronary heart disease (CHD).
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23 March 2007
AstraZeneca Names Shanghai Site As Initial Base for New Innovation Centre China |
AstraZeneca today announced Shanghai’s Zhangjiang Hi-Tech Park as the initial base for its new Innovation Centre China (ICC).
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21 March 2007
AstraZeneca Inaugurates State-of-the-Art Global Process R&D lab in Bangalore |
AstraZeneca today inaugurated a new state-of-the-art Process and Development (PR&D) laboratory next to its R&D centre in Bangalore, India.
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19 March 2007
Coronary Artery Disease ARISE Trial Showed AGI-1067 Did Not Meet Primary Endpoint |
AstraZeneca today announced that its collaboration partner AtheroGenics, Inc. (Nasdaq: AGIX) revealed first results from the ARISE (Aggressive Reduction of Inflammation Stops Events) phase III clinical outcomes trial which studied AGI-1067, an investigational anti-atherosclerotic agent with antioxidant and anti-inflammatory effects, in patients with coronary artery disease (CAD).
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18 March 2007
SEROQUEL® Sustained Release Schizophrenia Data presented at ECP Congress in Madrid |
AstraZeneca today announced clinical trial data for SEROQUEL® sustained release formulation (quetiapine fumarate sustained release), at the European Congress of Psychiatry (ECP) in Madrid. The data demonstrated that the SEROQUEL® sustained release formulation (quetiapine fumarate sustained release), administered once daily, significantly improved symptoms associated with schizophrenia (measured by PANSS) and increased the time to psychiatric relapse, when administered through a three-step dose initiation aimed at reaching the effective dose range on the second day of treatment.
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1 March 2007
AstraZeneca Issues 2006 Annual Report |
AstraZeneca today published its 2006 Annual Report and Form 20-F Information, its 2006 Annual Review and its 2006 Corporate Responsibility Summary Report. These documents are available on the company’s website, www.astrazeneca.com/annualreport.
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22 February 2007
AstraZeneca Announces Investment in $120m Laboratory for Process Research and Development at its Macclesfield Site, Cheshire, UK |
AstraZeneca is to invest $120 million in a new Process Research and Development (PR&D) Laboratory at its Macclesfield site, Cheshire, adding to the company’s significant investment in the UK over recent years.
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15 February 2007
AstraZeneca Wins Second Award for Investment in China |
AstraZeneca has won the 48 Club Group award for UK Outward Investor of the Year 2007 recognising the company’s considerable investment in China. The award was handed over at a ceremony at The Guildhall in London today.
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1 February 2007
Fourth Quarter and Full Year Results 2006 |
“AstraZeneca reports strong financial results for 2006, with EPS up 34 percent, and progress in strengthening the pipeline; Company continues to drive productivity improvements.”
AstraZeneca PLC - Fourth Quarter and Full Year Results 2006
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1 February 2007
AstraZeneca Acquires Arrow Therapeutics To Broaden Anti-Infective Capabilities |
AstraZeneca today announced an agreement to acquire Arrow Therapeutics Ltd., a privately owned UK biotechnology company, focused on the discovery and development of anti-viral therapies. The total share capital of Arrow Therapeutics will be purchased for $150m cash, subject to debt and working capital adjustment. The transaction is expected to close early in 2007.
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31 January 2007
AstraZeneca and Palatin Technologies Announce Worldwide Collaboration to Discover, Develop and Commercialise Obesity Compounds |
AstraZeneca and Palatin Technologies (AMEX: PTN) today announced an exclusive global licensing and research collaboration agreement to discover, develop and commercialise small molecule compounds that target melanocortin receptors.
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22 January 2007
AstraZeneca Makes $100M Research Investment In Boston |
Expansion Of R&D Boston To Create Up To 100 New Scientific Jobs
AstraZeneca today announced a $100m research investment to strategically boost work in the infectious disease area and continue its incremental growth in cancer research at its R&D center near Boston, Massachusetts.
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11 January 2007
AstraZeneca and Bristol-Myers Squibb Announce Worldwide Collaboration To Develop And Commercialise Diabetes Compounds |
Deal A Significant Step In Strengthening AstraZeneca’s Late Stage Pipeline Partnership Aligned with Bristol-Myers Squibb Company Strategy
AstraZeneca and Bristol-Myers Squibb Company (NYSE:BMY) (“companies”) today announced a collaboration to develop and commercialise two investigational compounds being studied for the treatment of Type 2 diabetes. Both compounds were discovered by Bristol-Myers Squibb.
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