Press release archive 2008

Wednesday, 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.
Friday, 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.
Thursday, 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.
Thursday, 11 December 2008
AstraZeneca Responds to FDA Joint Advisory Committees’ Recommendation on Symbicort 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).
Monday, 8 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.
Monday, 8 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.
Wednesday, 3 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.
Friday, 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).
Tuesday, 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.
Tuesday, 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.