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
In 2024, the ECDC published a detailed review of flu vaccine studies [1]. In particular, the report examined published trials of newer flu vaccines. As is well known, the older vaccines provide significant protection, but efficacy is diminished in certain populations. Especially the elderly are at an increased risk of Continue reading INFLUENZA VACCINATION IN THE ELDERLY