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28 December 2001
AstraZeneca submits clinical data for IRESSA (ZD1839) – a new class of anti-cancer treatment - in the USA |
AstraZeneca today announced that it has submitted a clinical data package to the U.S. Food and Drug Administration (FDA) in support of IRESSA (ZD1839) as monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in patients who have failed on previous chemotherapy regimens. IRESSA has been granted fast track review by the US authorities for this indication.
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21 December 2001
ASTRAZENECA SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO FDA FOR CASODEX 150 MG FOR THE TREATMENT OF EARLY STAGE PROSTATE CANCER |
AstraZeneca today announced that a supplemental New Drug Application (sNDA) has been filed with the U.S. Food and Drug Administration (FDA) for the company’s oral, once-daily hormonal medication Casodex (bicalutamide 150mg) for the treatment of early stage non-metastatic prostate cancer.
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20 December 2001
AstraZeneca and Lilly Collaborate on Clinical Trial Programmes
To Study IRESSA™ (ZD1839) In Combination With Gemzar® (Gemcitabine) For the Treatment of Various Cancers
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AstraZeneca and Eli Lilly Company today announced their clinical collaboration to evaluate the benefits of IRESSA™ (ZD1839) in combination with Gemzar® (gemcitabine) for the treatment of various cancers. The clinical collaboration, which will be jointly funded by both companies, will initially assess the combination of the two treatments as part of a Phase II clinical trial programme involving patients with advanced stage non-small cell lung cancer (NSCLC) and bladder cancer. The companies also plan to extend their collaboration to a clinical trial programme which will evaluate the combination of IRESSA and Gemzar in the treatment of various cancers, including breast and ovarian cancers. The clinical collaboration supplements an ongoing Phase III clinical trial, which is investigating the benefits of IRESSA in combination with Gemzar and cisplatin in NSCLC.
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11 December 2001
NEW DATA ON ARIMIDEX® HERALD ENTRY INTO EARLY BREAST CANCER |
AstraZeneca today announced that new data presented at the San Antonio Breast Cancer Meeting demonstrate for the first time that leading aromatase inhibitor Arimidex ® is significantly more effective and has important tolerability benefits compared with the current gold standard, tamoxifen, as an adjuvant treatment in postmenopausal women with early breast cancer.
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3 December 2001
ASTRAZENECA'S COMMERCIAL STRENGTH AND EXCELLENT PIPELINE TO DRIVE GROWTH AND ENSURE SUCCESS IN COMING YEARS |
AstraZeneca today presents a business update to a meeting of analysts in London.
Download the
press release
and the
pipeline table
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26 November 2001
ASTRAZENECA RECEIVES SIX MONTHS’ MARKET EXCLUSIVITY FOR ZESTRIL® (LISINOPRIL) |
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) granted six months’ market exclusivity for the ACE inhibitor ZESTRIL® (lisinopril) after the company complied with the FDA’s written request for information on the use of the medication in children.
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1 November 2001
FIRST PHASE II STUDY RESULTS SHOW ANTI-TUMOUR ACTIVITY WITH IRESSA™ IN ADVANCED
NON-SMALL CELL LUNG CANCER
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Preliminary data from the first pivotal phase II trial, presented today at the
12th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Miami, USA, demonstrate that when used as a second or third-line treatment, IRESSA™ leads to overall disease control in more than 50 per cent of unselected
[1] patients with advanced non-small cell lung cancer (NSCLC) who have failed previous platinum-based therapy. These initial results also suggest that IRESSA™ is generally well tolerated at both 250mg/day and 500mg/day.
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31 October 2001
ASTRAZENECA WINS GENERIC OMEPRAZOLE CASE IN NORWAY |
AstraZeneca today announced that the Oslo Byrett (Oslo City Court) in Norway found that a generic omeprazole product marketed by Scandinavian Pharmaceuticals-Generics AB (Scand Pharm) infringes AstraZeneca’s formulation patent for omeprazole, the substance used in Losec. At the same time, the Court declared AstraZeneca’s omeprazole formulation patent valid.
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24 October 2001
ASTRAZENECA PLC THIRD QUARTER RESULTS 2001
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Download the
narrative
and the
figures.
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23 October 2001
PRILOSEC US LITIGATION |
AstraZeneca today announced that it had received confirmation that its pending litigation to defend its patents associated with Prilosec in the US will go to trial in a case to be heard by Judge Jones commencing in New York on December 5th 2001.
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19 October 2001
ZD1839 IRESSA DATA |
AstraZeneca is encouraged by the positive results from IDEAL 1 (IRESSA Dose Evaluation in Advanced Lung cancer), the first pivotal study of ZD1839 (IRESSA) in non-small-cell-lung-cancer (NSCLC) and looks forward to the presentation of these phase II data at the 12th AACR-NCI-EORTC International Conference on "Molecular Targets and Cancer Therapeutics" in Miami, USA. Whilst the abstract of the data is available on www.aacr.org, the full results from IDEAL 1 will not be presented until Thursday, November 1, 2001, and the requirements of the AACR-NCI-EORTC scientific committee preclude discussion of the data presented in the abstract by the authors or the company until the day of the presentation.
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9 October 2001
NEXIUM® OUTPERFORMS LANSOPRAZOLE IN FIRST HEAD-TO-HEAD CLINICAL TRIALS |
Stanhope Gate, London, UK - The long-awaited results of head-to-head clinical trials between AstraZeneca’s newest proton pump inhibitor (PPI) therapy, Nexium® (esomeprazole), and its principal competitor, lansoprazole, were released today at the United European Gastroenterology Week (UEGW) in Amsterdam.
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28 September 2001
Government Minister opens 45 million GBP new science facility at AstraZeneca R&D Charnwood |
AstraZeneca announces the opening of one of Europe’s most technically advanced Pharmaceutical Development Facilities at its R&D site at Charnwood, near Loughborough, Leics. The 45 million GBP state-of-the-art facility is dedicated to providing supplies of potential new medicines for worldwide clinical trials and to developing the manufacturing processes required for eventual transfer to large-scale production.
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17 September 2001
ASTRAZENECA RECEIVES FIRST REGULATORY APPROVALS FOR CASODEX™ 150MG IN EARLY PROSTATE CANCER |
AstraZeneca has gained its first approval for Casodex™ (bicalutamide) 150mg for the treatment of early stages of prostate cancer in the United Kingdom. Casodex™ 150mg represents the first once daily drug therapy available for treatment of the early stages of this disease.
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26 July 2001
ASTRAZENECA PLC HALF YEAR RESULTS 2001 |
Download the narrative and the figures.
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25 July 2001
ASTRAZENECA APPOINTS NEW NON - EXECUTIVE DIRECTOR |
AstraZeneca PLC announces the appointment, with effect from 24 September 2001, of Jane E. Henney, M.D. as a non-executive Director.
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10 July 2001
NEW DATA SUPPORT THE EFFICACY AND SAFETY OF THE NOVEL ORAL ANTICOAGULANT EXANTA® |
The presentation of a wide range of data at the 18th International Society on Thrombosis and Haemostasis meeting (ISTH) in Paris this week, provided new evidence to support the efficacy and safety of Exanta®, which is set to be the first new oral anticoagulant since warfarin was introduced over 50 years ago.
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27 June 2001
ASTRAZENECA SUBMITS ITS NEW SUPERSTATIN, CRESTOR™, FOR REGULATORY APPROVAL IN THE US & EUROPE. DEVELOPMENT OF VIOZAN™ COPD TREATMENT TO BE DISCONTINUED; RESOURCES TO BE REALLOCATED TO MORE PROMISING PRODUCTS IN R&D PIPELINE |
CRESTOR™
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26 June 2001
ASTRAZENECA SUBMITS ITS NEW SUPERSTATIN, CRESTOR, FOR REGULATORY APPROVAL IN THE US & EUROPE. DEVELOPMENT OF VIOZAN COPD TREATMENT TO BE DISCONTINUED; RESOURCES TO BE REALLOCATED TO MORE PROMISING PRODUCTS IN R&D PIPELINE |
AstraZeneca announced today that the regulatory file for Crestor (rosuvastatin), a new statin for lipid lowering, has been submitted in the USA and Europe and that it had discontinued further development of Viozan, the D2B2 agonist for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
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20 June 2001
ASTRAZENECA OBTAINS APPROVAL FOR ZOMIG® MIGRAINE TREATMENT IN JAPAN |
AstraZeneca today received approval to market Zomig® for migraine treatment in Japan - the first, second generation triptan type of medicine to be approved there.
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2 May 2001
ASTRAZENECA RECEIVES SIX MONTHS' MARKET EXCLUSIVITY FOR PRILOSEC® |
AstraZeneca today announced that the US Food and Drug
Administration (FDA) granted six months' market exclusivity for Prilosec®
(omeprazole), after the company complied with the FDA's formal request for
information on the use of the prescription medication in children. The additional six
months' exclusivity will be added to all of the relevant patents for Prilosec®.
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2 May 2001
COURT DENIES GENERIC'S APPLICATION FOR SUMMARY JUDGEMENT ON PRILOSEC® PATENT |
AstraZeneca announced today that the United States District Court for the Southern District of New York has denied a summary judgement motion filed by Reddy-Cheminor alleging invalidity of a patent (US patent no:4,255,431) at issue in a lawsuit. The patent relates to omeprazole, the active ingredient in Prilosec®, a treatment for stomach acid disorders.
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28 April 2001
ASTRAZENECA OPENS NEW $100M PHARMACEUTICALS PLANT IN CHINA |
AstraZeneca today inaugurates a new $100m manufacturing plant in China - one of the
largest investments by a Western pharmaceuticals company in the People's Republic.
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26 April 2001
ASTRAZENECA PLC FIRST QUARTER RESULTS 2001, 26 April 2001 |
Download the narrative and the figures.
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25 April 2001
ASTRAZENECA INVESTS $10M IN BANGALORE LABORATORIES |
AstraZeneca PLC today announced plans for investment in India to create a centre of excellence at its facility in Bangalore for the discovery and development of new medicines of importance to the developing world.
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23 April 2001
ASTRAZENECA FILES LAWSUIT AGAINST APOTEX CORPORATION AND TORPHARM FOR PATENT INFRINGEMENT |
AstraZeneca confirmed today that it has filed a lawsuit in Illinois against Apotex Corporation and Torpharm for patent infringement.
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9 April 2001
RESULTS FROM LARGEST EVER PROSTATE CANCER STUDY SHOW ASTRAZENECA'S CASODEX ALMOST HALVES RISK OF DISEASE PROGRESSION |
First analysis of results from the largest ever study of its type announced today at the 16th annual meeting of the European Association of Urology shows that AstraZeneca's treatment, Casodex™ (bicalutamide) 150mg, cuts the risk of disease progression by almost half in patients with localised or locally advanced prostate cancer.
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30 March 2001
ASTRAZENECA SUBMITS NEW DRUG APPLICATION (NDA) TO FDA FOR NEW TYPE OF BREAST CANCER TREATMENT |
AstraZeneca today announced the submission of a new drug application (NDA), requesting Priority Review with the U.S. Food and Drug Administration (FDA) for Faslodex™, for treatment of locally advanced or metastatic breast cancer in postmenopausal women who have previously progressed following hormonal therapy.
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29 March 2001
ASTRAZENECA'S ENTOCORT™ (budesonide modified-release capsules) GRANTED PRIORITY REVIEW STATUS BY THE FDA |
AstraZeneca today announced that its New Drug Application (NDA) for Entocort™ (budesonide modified-release capsules) has been filed for the treatment of mild to moderate active Crohn's disease. The application, which was submitted to the Food and Drug Administration (FDA) on January 24, 2001, has been granted priority review status by the agency.
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28 March 2001
ASTRAZENECA MAKES FIRST REGULATORY SUBMISSION FOR USE OF 'CASODEX™' 150MG IN EARLY PROSTATE CANCER |
AstraZeneca today submitted a dossier to the Medicines Control Agency, the UK regulatory authority, for the use of Casodex™ (bicalutamide) 150mg in the treatment of localised and locally advanced prostate cancer - Early Prostate Cancer (EPC). This is the first submission, two years earlier than the planned date, and will be followed by subsequent submissions around the world, with the objective of providing clinicians and patients with an additional treatment option for the early stages of prostate cancer.
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27 March 2001
ASTRAZENECA INVESTS $109 MILLION IN NEW FACILITIES AT CHESHIRE RESEARCH AND DEVELOPMENT CENTRE |
AstraZeneca is investing $109 million (over £70 million) for new laboratories and office accommodation at its major research and development site at Alderley Park in Cheshire, UK.
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20 March 2001
ASTRAZENECA PRESENTS NEW PHASE III CRESTOR DATA CONFIRMING EXCITING POTENTIAL |
AstraZeneca today presents Phase III clinical trial results of its superstatin, Crestor (rosuvastatin - previously known as ZD4522), at the American College of Cardiology (ACC), in Orlando, Florida. The data show that:
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5 March 2001
ASTRAZENECA PLANS EXPANSION OF JAPANESE BUSINESS BASE WITH $47m INVESTMENT |
AstraZeneca today showed commitment to continuing to expand its business base in Japan by announcing plans to invest 5.5bn yen ($47m) in manufacturing and distribution facilities.
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28 February 2001
ASTRAZENECA COMPLETES SALE OF CORBY PACKAGING PLANT |
AstraZeneca today announced it has completed the sale of its packaging plant at Corby, Northants, to PCI Services, of the US.
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23 February 2001
ASTRAZENECA COMPLETES DEAL TO BUY CONTROLLING STAKE IN ASTRA-IDL LTD. |
AstraZeneca today announced it has completed a transaction to buy a controlling stake in Astra-IDL, based in Bangalore, India.
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21 February 2001
FDA APPROVES ASTRAZENECA's NEXIUM™ WITH COMPREHENSIVE SET OF INDICATIONS |
London - AstraZeneca confirms it will launch Nexium™ during March in the US, following its approval by the US Food and Drug Administration (FDA) and the announcement of the catalogue price to wholesalers.
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20 February 2001
SWEDISH PATENT COURT UPHOLDS ASTRAZENECA OMEPRAZOLE SPC |
AstraZeneca today announced that the Swedish Court of Patent Appeal has ruled that one of the company's Supplementary Protection Certificates (SPC) in Sweden for omeprazole, the active ingredient in Losec®, has not expired. The SPC expires in February, 2003.
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14 February 2001
ASTRAZENECA GAINS FDA APPROVAL FOR ZOMIG FAST MELT FORMULATION |
AstraZeneca today announced that it has gained approval from the US Food and Drug Administration (FDA) for its fast melt formulation of Zomig for the treatment of acute migraine in adults.
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8 February 2001
ASTRAZENECA FULL YEAR RESULTS 2000 |
View the narrative (Adobe document, 39KB) and figures (Adobe document, 45KB.)
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6 February 2001
FDA APPROVES ASTRAZENECA'S TOPROL-XL® FOR HEART FAILURE |
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved Toprol-XL® (metoprolol CR/XL) extended-release tablets for the treatment of stable, symptomatic (New York Heart Association Class II or III) heart failure of ischemic, hypertensive or cardiomyopathic origin. In a landmark clinical trial, Toprol-XL® has been shown to decrease the rate of mortality plus hospitalisation, largely through a reduction in cardiovascular mortality and hospitalisation for heart failure. The new heart failure indication is in addition to the existing use of Toprol-XL® in treating hypertension and angina pectoris.
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1 February 2001
ASTRAZENECA & IBM SIGN GLOBAL STRATEGIC OUTSOURCING AGREEMENT WORTH $1.7 billion |
One of the world's largest pharmaceuticals companies - AstraZeneca - and IBM, the world's largest information technology company, today announced that they had signed a global strategic outsourcing agreement worth $1.7 billion over seven years. The agreement, covering the provision of IT infrastructure services to 45 countries, is the largest of its kind in the pharmaceuticals industry.
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19 January 2001
ASTRAZENECA SELLS DENTAL LOCAL ANAESTHETIC BUSINESS TO DENTSPLY INTERNATIONAL INC.
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AstraZeneca announced today its decision to divest its dental range of local anaesthetics to DENTSPLY International, Inc. AstraZeneca's portfolio of dental local anaesthetics includes brand names such as Xylocaine®, Citanest® and Polocaine® /Carbocaine. AstraZeneca will retain the ownership of these local anaesthetic brand names but will license the rights to DENTSPLY for their dental use. DENTSPLY has also acquired full rights to Oraqix -- AstraZeneca's new dental gel for scaling and root planning, which is currently in Stage III clinical trials. The agreement is worth $136.5 million plus future royalty payments on Oraqix.
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15 January 2001
ASTRAZENECA INVESTS OVER $60 MILLION IN EXPANDED PRODUCTION FACILITIES FOR 'SEROQUEL' |
AstraZeneca is investing $60 million (over £37 million) at its manufacturing site in Macclesfield, Cheshire, UK, to meet the rapid growth in global demand for 'Seroquel', the atypical antipsychotic.
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9 January 2001
GENERIC CHALLENGE TO LOSEC® WITHDRAWN IN CANADA |
AstraZeneca today announced that the Canadian Federal Court has ordered that the proceedings against Genpharm Inc are deemed to be withdrawn, following the earlier rejection of a regulatory application by Genpharm for generic omeprazole, thus rendering the court proceedings moot.
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4 January 2001
SYMBICORT® GAINS EUROPEAN UNION MUTUAL RECOGNITION APPROVAL FOR ASTHMA CONTROL |
AstraZeneca announced today that Symbicort®, a new and innovative treatment for asthma, has been granted approval through the Mutual Recognition Procedure (MRP) in 14 European Union (EU) states plus Norway and Iceland. This follows initial approval of Symbicort in Sweden in August 2000. Sweden acted as the reference member state for the MRP application. In addition to these approvals, Symbicort has been approved in Switzerland, and applications have been submitted in both Canada and Australia.
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