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New diagnostic test soon ready for the market
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Björn Arvidsson: Det ska vara lätt att göra rätt
Små och medelstora life science-företag möter många utmaningar på sin utvecklingsresa, där samverkan med våra myndigheter inte borde bidra till utmaningarna, utan tvärtom skapa möjligheter för dem. Det skriver STUNS Life science verksamhetschef Björn Arvidsson.
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Drug development creates new challenges for regulators
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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.