Clinical / R&D
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Latest From Research & Development
Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.
From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.
Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.
The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.
With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
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