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AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive DisorderEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Major Depressive Disorder (MDD) in adult patients.
Source: AstraZeneca - December 24, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca and MAP Pharmaceuticals Announce Worldwide Collaboration To Develop and Commercialise Unit Dose BudesonideEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and MAP Pharmaceuticals, Inc. announced today an exclusive worldwide agreement to develop and commercialise Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulised formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for paediatric asthma and is currently in Phase III clinical development. UDB has the potential to be nebulised more quickly and at a lower nominal dose than the commercially available product.
Source: AstraZeneca - December 19, 2008 Category: Pharmaceuticals Source Type: organizations

12 - DecemberEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

11 - NovemberEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

09 - SeptemberEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

08 - AugustEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

07 - JulyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

06 - JuneEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

05 - MayEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

04 - AprilEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

03 - MarchEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

02 - FebruaryEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

01 - JanuaryEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - December 18, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Responds to FDA Joint Advisory Committees’ Recommendation on SymbicortEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 11 December 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) – including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee – completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded that the benefits of AstraZeneca’s SYMBICORT (budesonide/formoterol fumarate dihydrate), a combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in adult and adolescent asthma patients.
Source: AstraZeneca - December 13, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Returns Worldwide Rights to IPI-504 and IPI-493 Development Programs to Infinity PharmaceuticalsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced that it has returned worldwide rights to Infinity Pharmaceuticals for the development and commercialisation of Infinity’s heat shock protein 90 (Hsp90) drug candidates IPI-504 (MEDI-561) and IPI-493, in development for the treatment of cancer and related conditions.
Source: AstraZeneca - December 11, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in SchizophreniaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and Targacept, Inc. today announced top-line results from a Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HALO trial.
Source: AstraZeneca - December 9, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca and Bristol-Myers Squibb Announce Expansion of Worldwide Collaboration to Develop and Commercialise Dapagliflozin in JapanEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and Bristol-Myers Squibb today announced expansion of their worldwide collaboration to include the development and commercialisation of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.
Source: AstraZeneca - December 9, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in SchizophreniaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and Targacept, Inc. today announced top-line results from a Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HALO trial.
Source: AstraZeneca - December 8, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca and Bristol-Myers Squibb Announce Expansion of Worldwide Collaboration to Develop and Commercialise Dapagliflozin in JapanEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and Bristol-Myers Squibb today announced expansion of their worldwide collaboration to include the development and commercialisation of dapagliflozin in Japan. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in Phase III clinical trials in several countries, including the U.S., to assess its efficacy and safety as a once-daily treatment for type 2 diabetes.
Source: AstraZeneca - December 8, 2008 Category: Pharmaceuticals Source Type: organizations

PN 400 Phase III Studies Show Clinically Meaningful Benefit in Reducing Gastric Ulcers Compared to Enteric-Coated NaproxenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca and POZEN Inc., co-development partner for the investigational compound PN 400, have announced today results from two Phase III studies, PN 400-301 and PN 400-302 comparing PN 400 (enteric-coated naproxen 500 mg and immediate release esomeprazole 20 mg) to enteric-coated naproxen 500 mg. These studies were conducted by POZEN under an agreed Special Protocol Assessment (SPA) with the FDA.
Source: AstraZeneca - December 3, 2008 Category: Pharmaceuticals Source Type: organizations

MedImmune Receives FDA Complete Response Letter on MotavizumabEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab. The CRL is in connection with the Biologics License Application (BLA) for motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease, which was submitted on 30 January 2008. Motavizumab is an investigational monoclonal antibody (MAb).
Source: AstraZeneca - November 29, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Settles US Pulmicort Respules Patent Litigation with TevaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA.
Source: AstraZeneca - November 27, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Provides Update on Agreement with Abraxis Biosciences for Co-Promotion of Abraxane in the USEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 19 November 2008, AstraZeneca entered into an agreement with Abraxis BioScience, LLC, under which, subject to the satisfaction of terms and conditions thereof, Abraxis would re-acquire exclusive rights to market ABRAXANE in the United States.
Source: AstraZeneca - November 25, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca to divest Nordic over-the-counter portfolioEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products predominantly sold in Sweden. The decision reinforces AstraZeneca’s strategy to focus on innovation in prescription medicines.
Source: AstraZeneca - November 21, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca to Realign Supply Chain to Improve Productivity and Move Closer to CustomersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca has today announced proposed changes to its global manufacturing and supply chain operations as part of its ongoing programme to improve efficiency across the business. The introduction of new manufacturing processes has brought further opportunities to drive efficiencies across the global supply chain. The company will also establish a regional packing strategy, to improve its ability to respond to customer requirements, while equipping the business for emerging markets growth.
Source: AstraZeneca - November 21, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca granted Temporary Restraining Order in PULMICORT RESPULES patent litigationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by the United States District Court for the District of New Jersey, halting sales of Teva’s budesonide inhalation suspension product, a generic version of AstraZeneca’s PULMICORT RESPULES treatment.
Source: AstraZeneca - November 21, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca to divest Nordic over-the-counter portfolioEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products predominantly sold in Sweden. The decision reinforces AstraZeneca’s strategy to focus on innovation in prescription medicines.
Source: AstraZeneca - November 20, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca to Realign Supply Chain to Improve Productivity and Move Closer to CustomersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca has today announced proposed changes to its global manufacturing and supply chain operations as part of its ongoing programme to improve efficiency across the business. The introduction of new manufacturing processes has brought further opportunities to drive efficiencies across the global supply chain. The company will also establish a regional packing strategy, to improve its ability to respond to customer requirements, while equipping the business for emerging markets growth.
Source: AstraZeneca - November 20, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca granted Temporary Restraining Order in PULMICORT RESPULES patent litigationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by the United States District Court for the District of New Jersey, halting sales of Teva’s budesonide inhalation suspension product, a generic version of AstraZeneca’s PULMICORT RESPULES treatment.
Source: AstraZeneca - November 20, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Enters Agreement for Authorized Generic Pulmicort RespulesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced that it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of budesonide inhalation suspension in the United States in response to the launch ‘at risk’ of a generic version of this product by Teva. Currently, the authorized generic product will be distributed in the 0.25 mg/2 mL and 0.5 mg/2 mL dosage strengths. Par Pharmaceutical began shipping the product today.
Source: AstraZeneca - November 19, 2008 Category: Pharmaceuticals Source Type: organizations

Phase III Studies Show That Vandetanib (ZACTIMA) Brings Clinical Benefits to Patients With Lung CancerEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced results from three Phase III studies of ZACTIMA (vandetanib) in combination with chemotherapy agents docetaxel (ZODIAC) and pemetrexed (ZEAL) and as monotherapy (ZEST) in non-small cell lung cancer (NSCLC).
Source: AstraZeneca - November 19, 2008 Category: Pharmaceuticals Source Type: organizations

FDA Responds to AstraZeneca’s Citizen Petition -- FDA Also Grants Approval for a Generic Version of Pulmicort RespulesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 18 November 2008, the US FDA responded to AstraZeneca's Citizen Petition surrounding the company's concern about the approval of any generic version of PULMICORT RESPULES® (budesonide inhalation suspension). While the FDA agreed with some of the company's concerns, other arguments in the Citizen Petition were denied.
Source: AstraZeneca - November 19, 2008 Category: Pharmaceuticals Source Type: organizations

SEROQUEL XR and SEROQUEL Approved in Europe for New Indications for the Treatment of Bipolar DisorderEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure (MRP) for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been licensed for moderate to severe manic episodes in bipolar disorder.
Source: AstraZeneca - November 13, 2008 Category: Pharmaceuticals Source Type: organizations

CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes StudyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
New data from the JUPITER study demonstrated that CRESTOR® (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.
Source: AstraZeneca - November 9, 2008 Category: Pharmaceuticals Source Type: organizations

CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes StudyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
New data from the JUPITER study demonstrated that CRESTOR® (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p
Source: AstraZeneca - November 9, 2008 Category: Pharmaceuticals Source Type: organizations

John Patterson to Retire from AstraZenecaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced that John Patterson, Executive Director, Development will retire from the company in March 2009.
Source: AstraZeneca - November 4, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca PLC Third Quarter and Nine Months Results 2008Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Source: AstraZeneca - October 30, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca PLC Third Quarter and Nine Months Results 2008Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca has delivered a robust set of results, and on the back of this, is raising financial guidance for the full year. Additionally good progress is being made on reshaping the cost base, including advancing innovation in research and development activities with greater productivity and efficiency.
Source: AstraZeneca - October 30, 2008 Category: Pharmaceuticals Source Type: organizations

AstraZeneca Announces European SEROQUEL XR Submission for the Treatment of Generalised Anxiety DisorderEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca today announced its submission of SEROQUEL XR (quetiapine fumarate extended release tablets) to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder (GAD). This is the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD.
Source: AstraZeneca - October 21, 2008 Category: Pharmaceuticals Source Type: organizations