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Latest From Research & Development

Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression

Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Clinical Trials Research & Development

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

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.


ImmunoOncology Clinical Trials

Takeda/Shire Merger: Five Things To Worry About

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Drug Review Research & Development

Galectin Plans To Head Into NASH Pivotal Studies Without Biopsy-Evaluated Endpoint

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.

Clinical Trials Liver & Hepatic

Why Four In Five Applications For PRIME Still Fail Two Years On: EMA Clarifies Expectations

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.

Market Access Europe

EMA’s PRIME Is Driving Innovation, But Too Early To Tell If Drugs Will Reach Patients Faster

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.

Market Access Research & Development
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