These press releases are for business and financial media.
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- Press release archive 2009
- 25 February 2009
- AstraZeneca To Participate In Tentative FDA Psychopharmacologic Drugs Advisory Committee AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 8 April 2009. AstraZeneca has been advised that at its meeting, the PDAC will discuss the safety and efficacy of supplemental new drug applications (sNDA) for SEROQUEL XR proposed for the treatment of major depressive disorder (MDD) and generalised anxiety disorder (GAD).
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- Press release archive 2009
- 24 February 2009
- AstraZeneca’s Partner, MAP Pharmaceuticals, Announces Phase III Study Of Unit Dose Budesonide In Children With Asthma Did Not Meet Primary Endpoints MAP Pharmaceuticals, Inc. announced yesterday that its initial Phase III clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in night-time and daytime composite symptom scores, in either of the doses evaluated when compared with placebo.
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- Press release archive 2009
- 29 January 2009
- AstraZeneca PLC Fourth Quarter and Full Year Results 2008 AstraZeneca has delivered a robust performance in an increasingly challenging market environment. Good headway is being made in further improving the efficiency of the organization, and the expansion in the scope of our restructuring efforts is another important step towards sustaining long-term competitiveness.
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- Press release archive 2009
- 29 January 2009
- AstraZeneca’s Partner, POZEN Informed By FDA That Gastric Ulcers Are Valid Primary Endpoint In PN 400 Trials POZEN Inc., AstraZeneca’s co-development partner for the investigational compound PN 400, has been informed that the US Food and Drug Administration (FDA) has completed its internal discussions and that there is no change to the previous agreements that gastric ulcer incidence is an acceptable primary endpoint for the PN 400 Phase III clinical programmes.
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- Press release archive 2009
- 06 January 2009
- MedImmune Submits Marketing Authorisation Application in European Union for Intranasal Vaccine to Prevent Seasonal Influenza MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza.
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- Press release archive 2008
- 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.
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- Press release archive 2008
- 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.
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- Press release archive 2008
- 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.
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- Press release archive 2008
- 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.
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