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Six New Drugs Get EMA Nod, Radius and Portola To Fight Rejections

Executive Summary

Two products that the European Medicines Agency this week said should not be authorized for sale in the EU are already approved in the US.

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Companies Reveal Likely EU Review Outcomes Against EMA Advice

The European Medicines Agency asks companies to wait until they know for certain whether their marketing authorization applications will be approved or not before making any public announcement. Despite this, some companies go public as soon as they hear an early, but non-binding, verdict. The Pink Sheet looks at the issue of “trend votes” and at the companies who decide not to wait.

Radius Braced For Second CHMP No For Abaloparatide

Another expected knockback by the European Medicines Agency's scientific committee is expected for Radius' lead product after the company revealed a negative trend vote for the osteoporosis therapy.

A Massive First For EU – CAR-T Therapies Kymriah and Yescarta Hoping For CHMP OK

Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?

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