Efter positiva resultat för Valneva: ”Ansökan till EMA skickas så snart som möjligt”

Efter att ha stoppats av Storbritannien ser det nu ljusare ut för Valnevas covid-19-vaccinkandidat sedan positiva fas III-resultat presenterats. Nu väntar ansökan till EMA. "Det behövs mer vaccin eftersom hela världen ska få tillgång till vaccin och kunna vaccinera sig", säger Valnevas Sverige-chef Janet Hoogstraate.

Sweden and Denmark – this is how they choose their strategies

Scandinavia’s two major powers in pharmaceutical research have developed strategies for growth in life science, and both countries aim to become world leaders.

ATMP-expert till Eliceras styrelse

Karin Hoogendoorn har valts in i styrelsen för Elicera Therapeutics.

Marie Gårdmark: Big data evidence generation drives change in the EU regulatory system

Rapid developments in technology have led to the possibility for the generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? In a column Marie Gårdmark, CEO and Senior Consultant at RegSmart Life Science, develops her views on this subject.

Column: Repurposing as a golden ticket to approval

"Hopefully, in the end, patients will be winners by receiving on-label treatments for which benefit-risk has been properly assessed." In a column Marie Gårdmark, CEO at RegSmart Life Science, reflects on drug repurposing.

SDS Life Science satsar på regulatorisk spetskompetens