Published in Physician Law Weekly, February 7th, 2007
This trend article is an immediate alert from NewsRx to identify the most recent news developments at AstraZeneca.
Report 1: AstraZeneca announced its intention to expand the development plan for CytoFab, a treatment for severe sepsis, with the addition of a 480-patient phase II study program.
The company has recently completed consultations with regulators in the U.S. and E.U. These consultations confirmed that a single phase III study could be sufficient for regulatory approval. Furthermore, to meet the regulatory needs of both agencies, it is required that AstraZeneca implement a...
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