Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism. Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial
There have been several articles on the China Pharma market recently, its development pipeline and the changes to the regulatory environment [1], [2], [3]. They paint a picture of R&D in transition; a provider of services becoming an innovator, a maturing pharma landscape that is increasingly more efficient and business-oriented, with Continue reading The Economist On China Pharma Going Global
There are studies that are bound to succeed, and those that are likely to fail. A failed trial is nothing to be proud of – and in this case, it was a gamble against overwhelming odds. We feel the Gilead marketing department was pushing their luck big time with this Continue reading Obeldesivir Fails in Yet Another Study