Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
US doctors seem to be very willing to start drugs earlier in disease, while their EU colleagues are slower and more conservative. Recent examples: the ever-wider indication for statins, the disproportionate uptake of drugs for attention-deficit / hyperactivity and opioids for pain relief. The new US HIV treatment guidelines are Continue reading HIV Therapy Guidance Recommendations Diverge, Show US Bias
As antibiotic resistance increases over the years, originally established susceptibility breakpoints (S-I-R) are becoming less relevant. This ‘creep’ towards higher MICs over time is a unique but well-known feature of antimicrobials ultimately making these drugs obsolete. In the past, FDA and CLSI did not bother to update breakpoints in Continue reading The Breakpoint Dilemma
Treating CMV was never easy making prophylaxis the preferred approach for HSCT patients. Since the late 80ies, trials using hyperimmune globulin have come up with mixed results. While treatment was usually safe, efficacy was a lot much harder to prove. More specific monoclonal ab preparations directed against immunodominant surface glycoproteins did not Continue reading CMV Hyperimmune Globulin Data Inconclusive but New Drug Shows Promise