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

Draft FDA Guidance for COCCIDIOIDOMYCOSIS

David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”.  He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS

Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria