A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of substantial clinical data, as anticipated in VCLS’ feasibility assessment.
Two years on, the client asked VCLS to provide expertise to identify the gaps in the studies and recommend a new approach.
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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…
