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Marie Gårdmark: Potential step change – EU regulators get to play with data
A new pilot from EMA is starting in September to assess wether the analysis of 'raw data' by regulatory authorities improves the evaluation of marketing approval for new medicines. Marie Grådmark writes in a column that she is looking forward to the outcome of the pilot to hopefully then understand if “in house” analyses actually will add value.
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Marie Gårdmark: New incentives for orphan products on its way
"Let’s hope that the learnings from development of new therapies for rare diseases will spill over to more common conditions, orphan products paving the wave for drug development in a broader context", writes Marie Gårdmark in a column.
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Elicera develops CAR-T against solid tumours – may become the first in the world
Today, there are five EU-approved CAR-T therapies, all focused on different types of blood cancer, but no one has yet succeeded in making the method work against solid tumours. At Gothenburg-based Elicera, they are working relentlessly to succeed in that field as well. “It is the largest field, and the potential is enormous,” says the company’s CEO Jamal El-Mosleh.
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Svenska Elicera utvecklar CAR-T mot solida tumörer – kan bli först i världen
Idag finns fem EU-godkända CAR T-terapier, alla inriktade på olika typer av blodcancer, men ännu har ingen fått metoden att fungera mot solida tumörer. På Göteborgsbaserade Elicera jobbar man för högtryck för att nå även dit. – Det är det största området och potentialen är enorm, säger företagets vd Jamal El-Mosleh.
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