Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It
After a single high dose of (8 or 10 mg/kg BW) of daptomycin IV, bone levels were measured in plasma and trabecular bone obtained during hip or knee surgery of 16 patients.[1] At the time of surgery, mean concentrations in plasma and synovial fluid were 39 and 22 µg/mL, respectively. Continue reading Adequate Penetration of Daptomycin Into Bone Tissue
The development history of glycopeptide drugs is anything but normal. Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration. The drug did superbly in a landmark endocarditis trial and everything looked rosy. Then we learned Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides