New BIOMARKER CONSORTIUM PROs

Aulus Cornelius Celsus wrote his famous book ‘De Medicina’ approximately 2000 years ago.  Living in the times of Caesar Augustus, little is known about his persona.  We are not even sure whether he was a practicing physician.  Many of his books were lost but Volume VIII was rediscovered in the Continue reading New BIOMARKER CONSORTIUM PROs

FDA Adboard on Tedizolid – Why?

FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair:  Looking at the reviewer’s slides, there was really no question about the drug’s efficacy.  Did tedizolid cure as many patients as linezolid?  Yes, it did.  Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority?  Yes, they Continue reading FDA Adboard on Tedizolid – Why?