NewLink’s Ebola vaccine receives positive recommendation by EU committee
NewLink Genetics Corp. announced that the European Medicines Agency Committee for Medicinal Products for Human Use has adopted a positive opinion recommending a conditional marketing authorization for the company’s investigational V920 Ebola Zaire vaccine, which it is developing in partnership with Merck & Co. Inc. The recommendation will now be reviewed by the European Commission, which, if it chooses to affirm the CHMP’s recommendation, will grant a centralized marketing authorization of the vaccine under the brand name Ervebo under a unified label valid in 31 European countries. The U.S. Food and Drug Administration has already granted priority review status for the investigational vaccine. The Ames-based company announced on Oct. 1 it plans to merge with Lumos Pharma Inc., an Austin, Texas-based biopharmaceutical company focused on development and commercialization of therapeutics for rare diseases.