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CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

 
• By Maureen Kenny

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will likely shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

EMA
The October meeting of the European Mediciines Agency's CHMP is taking place this week • Source: Shutterstock

Around ten companies whose products are at the later stages of evaluation at the European Medicines Agency will find out soon whether the agency has remaining concerns with their marketing authorization applications. The products include Ariad’s targeted kinase inhibitor, Alunbrig (brigatinib), and Portola’s Factor Xa anticoagulant, Bevyxxa (betrixaban).

One of the many things the EMA’s Committee for Medicinal Products for Human Use does at its monthly meetings with regard to products that are under review is adopt the lists of outstanding issues (LoOIs) it has at the 180-day point in the 210-day-long evaluation procedure (day 120 for products being evaluated

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