Allphase Pharma Consulting, LLC
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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 Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials
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 Continue reading REGULATORY INTERACTIONS – 1
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 Continue reading NANOBODIES FOR AUTOIMMUNE DISEASES
It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3]. It Continue reading The 10 x ’20 Initiative – A Retrospective
Today we discuss the group of BAFF/APRIL inhibitors, specifically the three TACI mAb constructs that are currently in development. They were tested in a broad gamut of B-cell indications but failed to show efficacy in many. So far, consistent clinical Continue reading BAFF / APRIL Inhibitors Homing in on IgAN