This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.
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The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under…
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In the fast-paced world of biotech innovation, time is of the essence. For European biotech ventures eyeing entry into the…
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Embarking on the journey to expand into the United States market is a pivotal moment for any European biotech company.…
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Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
