J&J To Get EU Fast-Track Decision On Apalutamide
J&J is hoping EU regulators will follow the US in fast-tracking the company’s prostate cancer franchise-extending drug apalutamide.
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Another hectic 12 months are anticipated at the US FDA as it is set to give its verdict on no fewer than 40 products in 2018. Here Scrip takes a look at 10 of the more interesting candidates approaching the market for the first time.
The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
Products submitted for approval in the EU in recent weeks include Amgen/UCB’s potential new treatment for osteoporosis, romosozumab, an iv formulation of GSK’s flu treatment, zanamivir, and avacopan, a new immunosuppressant from ChemoCentryx that is getting support through the EMA’s PRIME scheme.