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Merck's Ebola vaccine candidate nabs accelerated review designations in the U.S. and Europe

Jul. 25, 2016 9:43 AM ETMerck & Co., Inc. (MRK) StockMRK, LUMOBy: Douglas W. House, SA News Editor1 Comment
  • Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
  • The FDA has tagged V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
  • The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
  • Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.

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