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Phase III Prostate Cancer Failures: Taxotere to Blame?

Had a Phase III failure? Don't believe the data. Trial design, concurrent therapies, patient selection, or even the conventional diagnostic indicator for the disease could be at fault, as illustrated by a handful of late-stage trip-ups during 2007.

If there’s anything to be drawn from three recent Phase III failures—two in prostate cancer, one in stroke, all run by small biotechs—it’s that these days, you don’t believe the data. Trial design, concurrent therapies, patient selection, or even the conventional diagnostic indicator for the disease could be at fault.

Take the two prostate cancer snafus. Late in October, GPC Biotech AG’s orally administered platinum-based chemotherapeutic, satraplatin, failed to show...

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In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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