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“We are Europe’s hotspot in life science”
The Medicon Valley Alliance has worked for competence development in life science in Denmark and Sweden for a quarter of a century. Anette Steenberg, CEO, sees the anniversary as a recognition of MVA’s explosive power.
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He is zooming in on topical preparations
According to Zelmic CEO David Sagna, topical products in drug development is a growing market, and to keep pace with the development, the company is awaiting approval for its new GMP facility.
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FDA-kommitté förordar Astra Zenecas nya astmabehandling
En rådgivande kommitté till den amerikanska läkemedelsmyndigheten FDA rekommenderar Astra Zenecas preparat PT027 som en behandling mot astma för vuxna, uppger bolaget i ett pressmeddelande.
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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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New rules for diagnostic products, but who will certify them? “An extreme shortage area”
In less than two weeks, new and stricter EU rules will enter into force for thousands of products used in important diagnoses of, among other things, cancer and Covid-19. However, not one single institute in the entire Nordic region is able to certify the diagnostics companies’ products according to the new regulations. “In the end, it risks affecting patients,” says Anna Lefèvre Skjöldebrand, CEO of Swedish Medtech.
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“Together Stockholm-Uppsala and Medicon Valley can make Scandinavia a leading life science region”
“Denmark, Sweden, Norway and Finland all have national life science strategies, but the Swedish strategy is the only one explicitly emphasizing the Nordic dimension. But what if the leading life science nations, Denmark and Sweden, joined forces, took the lead and pioneered Nordic life science collaboration? Wouldn´t we then be able to "bake a bigger cake?", writes Anette Steenberg and Ulf G. Andersson in a debate article.
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