Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All the while FDA lobbyists are singing the praises of an Continue reading FDA Needs Radical Reform
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to a single-digit factor. In other words, as more data accrue, Continue reading The Letermovir Top-Line Results are Out – Or Are They?
Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead of 250 mg IM) or with azithromycin combination therapy. Worse Continue reading GC Therapy – Shooting for the Stars