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Is there is a new trend in the journal world: publication of interim analysis (IA) results? The NEJM recently published two articles back to back, both highlighting 9 month ‘interim’ data from Phase 3 pivotal trials in IgAN. The primary efficacy endpoint used in either study was UPCR at 9 Continue reading IgAN Therapeutics – The Race is On
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?