Allphase Pharma Consulting, LLC
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Shortly after Domagk and Hörlein announced their discovery of the antibacterial properties of the dye sulfamidochrysoidine (Prontosil) in 1935, numerous chemical companies set out to modify the chemical structure. They soon recognized the sulfa component as the true antibacterial and produced an incredible number of derivatives (more than 5000 different compounds!!) by 1945.[1, Continue reading The Rapid Rise of Sulfonamide Diversity
Several articles in the April 7 issue of BMJ were devoted to the epic battle fought by BMJ and Cochrane to gain unfettered access to the Tamiflu® and Relenza® data. Not just some data, but all the data. Considering that only 2 out of 10 Tamiflu studies were published in Continue reading The War about Data Access
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?