Pipeline Watch: Phase III Readouts For Rapastinel, VX-445 And Mirvetuximab Soravtansine
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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The biotech’s hopes for an accelerated approval on subgroup data were dashed by the US FDA, but it will work with the agency to design a Phase III focused on highly FRα-positive patients.
The European Commission has granted a marketing authorization for UCB and Amgen’s bone-building MAb, romosozumab, and first launches are expected in the first half of 2020; patient groups suggest that the prevention and treatment of fragility fractures has not attracted the attention it deserves.
Turku, Finland-based Forendo Pharma has entered into a license and collaboration deal with Novartis involving the identification of novel drugs to treat chronic liver diseases.