Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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 is caused by large aggregates of vWF, a protein which Continue reading NANOBODIES FOR AUTOIMMUNE DISEASES
Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things about the drug. It also highlighted how strategic missteps can Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin
Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria