New diagnostic test soon ready for the market

Calliditas siktar mot marknadsgodkännande

Nu ska Calliditas fokusera på att få sitt läkemedel mot Bergers sjukdom godkänt, sedan positiva resultat uppnåtts i fas III.

Calliditas har nått goda resultat i fas-3 studie

Företaget planerar nu söka marknadsgodkännande för njurläkemedlet Nefecon.

Drug development creates new challenges for regulators

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.