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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including BioCryst's Orladeyo for the routine prevention of recurrent attacks of hereditary angioedema.
New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.
Rhizen is entitled to royalties on net sales of US FDA-approved Ukoniq, being commercialized by partner TG Therapeutics, and expects to take the lymphoma treatment to India. CEO suggests the first-in-class PI3K/CK1 epsilon inhibitor, discovered by Rhizen, bests competitors including Bayer's Aliqopa.
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