Idefirix PDUFA Date and the IdeS of March

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 Economist On China Pharma Going Global

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

OLOROFIM in a TIGHT SPOT

Regulatory and development status of Olorofim, a novel antifungal. Continue reading OLOROFIM in a TIGHT SPOT