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Marie Gårdmark: Do EMA and FDA talk to each other?

Of course they do! The collaboration started already in 2003, writes Marie Gårdmark in a column.

Tar bort behovet av levertransplantation

Hittills har den enda botande behandlingen vid akut hepatisk porfyri, AHP, varit levertransplantation. Nu kan det nya läkemedlet givosiran, som fick en prioriterad och uppskyndad bedömning av EMA, göra att sådana ingrepp inte behöver genomföras, men det är oklart när det når fram till den svenska marknaden.

Krönika: Can regulators keep up with innovation?

New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market, exemplified by CAR-T cells, and the research pipeline is promising. In addition, the medical device field is constantly growing creating new solutions to address patient needs.