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EU Accelerated Assessment Tracker

At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.

Europe Drug Review

Japan Nods Include Global First For Duvroq, First Local Biosimilar Humira

Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, world-first nods for the country’s second HIF-PH inhibitor and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.

Japan Approvals

Vertex's Triple CF Combo Gets EU Approval Nod; Rejection For Daiichi Sankyo

EU approval is likely for the eight medicines that got the thumbs up this week from the European Medicines Agency's drug evaluation committee, the CHMP. The panel held fire on one product it had been considering and also issued its first rejection of 2020.

Drug Review Europe

US FDA May Publish Pre-Recorded Presentations Before Virtual Advisory Committee Meetings

The move is intended to streamline virtual advisory committee meetings, FDA official says.

Manufacturing Coronavirus COVID-19
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