Isatuximab EU Approval Decision Due
Sanofi Product Is On List of Hopefuls At CHMP Meeting
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.
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Zolgensma should receive a conditional approval, says the European Medicines Agency’s drug evaluation committee, the CHMP.
If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months.
Mylan says its ‘durable’ business model has helped it to withstand pressures from adverse industry trends in 2019, boosted by $1bn in sales from newly-launched products. However, negative currency effects cut the firm’s sales growth from 3% at constant currencies to 1% as reported.