AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers

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- 24 December 2008
- AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive Disorder 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.
- 19 December 2008
- AstraZeneca and MAP Pharmaceuticals Announce Worldwide Collaboration To Develop and Commercialise Unit Dose Budesonide 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.
- 11 December 2008
- AstraZeneca Responds to FDA Joint Advisory Committees’ Recommendation on Symbicort
- 11 December 2008
- AstraZeneca Returns Worldwide Rights to IPI-504 and IPI-493 Development Programs to Infinity Pharmaceuticals 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.
- 08 December 2008
- AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in Schizophrenia 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.
- 08 December 2008
- AstraZeneca and Bristol-Myers Squibb Announce Expansion of Worldwide Collaboration to Develop and Commercialise Dapagliflozin in Japan 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.
- 03 December 2008
- PN 400 Phase III Studies Show Clinically Meaningful Benefit in Reducing Gastric Ulcers Compared to Enteric-Coated Naproxen 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.
- 28 November 2008
- MedImmune Receives FDA Complete Response Letter on Motavizumab 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).
- 25 November 2008
- AstraZeneca Settles US Pulmicort Respules Patent Litigation with Teva 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.
- 25 November 2008
- AstraZeneca Provides Update on Agreement with Abraxis Biosciences for Co-Promotion of Abraxane in the US 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.
- 20 November 2008
- AstraZeneca to divest Nordic over-the-counter portfolio 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.
- 20 November 2008
- AstraZeneca to Realign Supply Chain to Improve Productivity and Move Closer to Customers 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.
- 20 November 2008
- AstraZeneca granted Temporary Restraining Order in PULMICORT RESPULES patent litigation 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.
- 19 November 2008
- AstraZeneca Enters Agreement for Authorized Generic Pulmicort Respules 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.
- 19 November 2008
- Phase III Studies Show That Vandetanib (ZACTIMA) Brings Clinical Benefits to Patients With Lung Cancer 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).
- 19 November 2008
- FDA Responds to AstraZeneca’s Citizen Petition -- FDA Also Grants Approval for a Generic Version of Pulmicort Respules 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.
- 13 November 2008
- SEROQUEL XR and SEROQUEL Approved in Europe for New Indications for the Treatment of Bipolar Disorder 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.
- 09 November 2008
- CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study 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.
- 04 November 2008
- John Patterson to Retire from AstraZeneca AstraZeneca today announced that John Patterson, Executive Director, Development will retire from the company in March 2009.
- 30 October 2008
- AstraZeneca PLC Third Quarter and Nine Months Results 2008 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.
- 21 October 2008
- AstraZeneca Announces European SEROQUEL XR Submission for the Treatment of Generalised Anxiety Disorder 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.
- 17 October 2008
- AstraZeneca and POZEN Informed of FDA Internal Review of Gastric Ulcers as a Primary Endpoint in Trials AstraZeneca and POZEN Inc., co-development partner for the investigational compound PN 400, have announced today that the U.S. Food and Drug Administration (FDA) has informed POZEN that it is conducting an internal review on the acceptability of endoscopic gastric ulcers as a primary endpoint in clinical studies. The FDA has not indicated when their internal review will be completed, although an FDA internal meeting has been scheduled to review this subject during the first quarter of 2009.
- 10 October 2008
- FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
- 24 September 2008
- US Court Denies Teva’s Motion For Summary Judgment In Pulmicort Respules Patent Litigation AstraZeneca today announced that the US District Court for the District of New Jersey has denied Teva’s Motion for Summary Judgment of no infringement in the PULMICORT RESPULES (budesonide inhalation suspension) patent litigation.
- 16 September 2008
- AstraZeneca and Targacept Announce Top-Line Results From Phase IIb Study of AZD3480 in Alzheimer’s Disease Results inconclusive, as primary outcome measure not statistically significant for either donepezil or AZD3480; results impacted by improvement in placebo group Improvements shown on secondary outcome measures ADCS-CGIC and MMSE Overall safety and tolerability profile comparable to placebo, with fewer GI-related AEs than donepezil Next steps include further analysis of full dataset and planned discussions with leading medical experts
- 12 September 2008
- AstraZeneca PLC Appoints New Non-Executive Director AstraZeneca today announced that Rudy Markham is to join the Board of Directors as a Non-Executive Director with immediate effect. Rudy Markham was formerly Chief Financial Officer of Unilever. He is currently a Non-Executive Director of Legal and General Group Plc, Standard Chartered PLC and United Parcel Service, Inc. He is also a member of Board of the Financial Reporting Council.
- 09 September 2008
- New Data for Investigational Diabetes Drug Saxagliptin Demonstrates Potential for Type 2 Diabetes Treatment New data presented for the first time at EASD 2008 Saxagliptin with metformin as initial combination therapy lowered A1C Improvements demonstrated across key measures of glucose control studied in treatment-naïve people with type 2 diabetes
- 08 September 2008
- Saxagliptin Improved Key Measures of Glucose Control When Added to a Sulphonylurea or Thiazolidinedione in People with Inadequately Controlled Type 2 Diabetes Results from two 24-week Phase III studies presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrate that saxagliptin produced reductions across all key measures of glucose control studied [glycosylated hemoglobin level (A1C), fasting plasma glucose (FPG) and postprandial glucose (PPG)] when added to a sulphonylurea (SU) or a thiazolidinedione (TZD) in people with inadequately controlled type 2 diabetes, compared with placebo added to either an increased dose of SU or a
- 14 August 2008
- AstraZeneca and Abbott Expand Relationship to Include Co-Promotion of CRESTOR® AstraZeneca and Abbott announced today that they have entered into an agreement for Abbott to promote AstraZeneca's CRESTOR® (rosuvastatin calcium), a medication used along with diet to reduce high cholesterol.
- 31 July 2008
- Second Quarter and Half Year Results 2008