These press releases are for business and financial media.
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- 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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- 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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- 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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- 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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- 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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