A Professional Service Provider for the Pharma Industry
The pivotal ConfIdeS study has finished enrollment and is now with the FDA. IdeS is imlifidase, with the brand name Idefirix. It has been conditionally approved by EMA and is on the market in Europe since 2020. Idefirix is a niche product, an orphan drug. It is a cysteine protease Continue reading Idefirix PDUFA Date and the IdeS of March
The 1st edition of Mandell’s textbook ‘Principles and Practice of Infectious Disease’ was published in 1979. It has grown ever since in size and numbers of chapters. Now in its 10th edition, it is and remains an impressive publication, a 2-volume set, a comprehensive reference textbook, kept up-to-date with periodic Continue reading Where are the Chloramphenicol Derivatives?
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