University of Nebraska

AstraZeneca establishes scientific review board for clinical trial data transparency

Thursday, March 19, 2015

AstraZeneca has created a scientific review board that will act independently to assess requests from external researchers, which includes patient level data. The board of independent clinicians and academics has been established as part of AZ’s commitment to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) Responsible Data Sharing Principles, as well as the new EMA Clinical Trial Policy and Regulation.

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FDA advisory committee recommends approval of Tiotropium Respimat COPD

Thursday, August 21, 2014

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) that existing data supports approval of Boehringer Ingelheim‘s investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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