Vascepa Gains European Filing Nod
No Rush In Search For Marketing Partner
On the cusp of US approval, Amarin must wait until late 2020 for EMA judgement
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Acasti’s omega-3 candidate drug CaPre missed the primary endpoint in TRILOGY-1 due to an unexplained high placebo effect, as AstraZeneca said its STRENGTH study was unlikely to show a treatment benefit.
A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.
Having achieved a turnaround in its R&D and commercial fortunes, AstraZeneca’s hopes the opening of a new research center will herald its next wave of novel therapies.