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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
Francis William Rogers Brambell was an Irish scientist who rose to prominence in the middle of the last century. He is remembered for 2 major accomplishments. First and foremost, his discovery that passive immunity is transferred from mother to baby. Based on research in various animal species on the transfer Continue reading Prof Brambell’s FcRn – The Story So Far
Sometimes we come across an article we wish we had read earlier. This was the case with the publication by Zhao and colleagues[1]. The article, now more than 12 years old, was written in the ‘early’ days of biological drug development, after the first wave of mAbs had already been Continue reading PK/PD of BIOLOGICALS