The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.

After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.

Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting. The drug has already secured reimbursement in Scotland, Sweden and Israel.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.