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Microbiological Response as Primary Efficacy Endpoint for Antibacterials

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We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious diseases we have the luxury of knowing exactly what causes Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials→

REGULATORY INTERACTIONS  – 1

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It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators.  There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS  – 1→

NANOBODIES FOR AUTOIMMUNE DISEASES

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Thrombotic thrombocytopenic purpura (TTP) is a devastating disease with a downhill course of neurologic, renal and cardiac complications leading to death at a young age if untreated.  Thrombocytopenia and thrombosis are its hallmark, with fever, anemia and neurologic deficits. It is caused by large aggregates of vWF, a protein which Continue reading NANOBODIES FOR AUTOIMMUNE DISEASES→