Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

HUMAN GENOME REPORTS DATA FROM ALBUFERON STUDY

Human Genome Sciences has reported 12-week interim results from a Phase IIb clinical trial of Albuferon (albumin- interferon alpha 2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C who are naïve to interferon alpha-based treatment regimens. The results demonstrate that Albuferon in combination with ribavirin was safe, well-tolerated and showed robust antiviral activity

The data warrant exploring the Albuferon 900-mcg and 1200-mcg doses at two-week intervals in Phase III clinical studies, noted the company.

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HUMAN GENOME REPORTS DATA FROM ALBUFERON STUDY

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