Notified body to leave Denmark in 2020

Norwegian Presafe has caught the Danish Medicines Agency and Medicoindustrien, the Danish industry association for medtech companies, unawares by deciding to close its notified body in Denmark. Medicoindustrien calls the decision “problematic” while the Danish Medicines Agency is now looking for opportunities to establish a new agency in the country.

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MSD's Keytruda fejler i mavekræftstudie

Immunterapien Keytruda fra amerikanske Merck/MSD har ikke kunnet overgå kemoterapi i andenlinjebehandling af patienter med kræft i mave eller spiserør. Lægemidlet blev for få måneder siden godkendt i indikationen i tredje linje.

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