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The newly passed US Food and Drug Administration's (FDA) Amendments Act (FDAAA) sets the stage for key improvements to postmarketing surveillance as well as the preapproval process.
Years of tinkering with the mouse immune system genes has finally produced a winner, with the approval of the first fully human monoclonal antibody made in a mouse. A real breakthrough or an incremental improvement? Christopher Thomas Scott investigates.
A survey of market trends for biotech products shows that only a handful out of more than one hundred biologics have been fueling the double-digit rise in revenues in the sector.
