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Five Drugs Set For EU Approval, Including Two Orphans

Executive Summary

The EU’s CHMP has recommended approval of a number of products including Pfizer’s Mylotarg for acute myeloid leukemia, Ammtek’s Amglidia for neonatal diabetes, and BioCryst Pharmaceuticals/Seqirus’ Alpivab for uncomplicated influenza.

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CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

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.

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