NewLink Genetics (NLNK) Announces Achievement of Two Ebola Zaire Vaccine Candidate Milestones by Merck (MRK) : streetinsider

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NewLink Genetics (NLNK) Announces Achievement of Two Ebola Zaire Vaccine Candidate Milestones by Merck (MRK)

NewLink Genetics (NLNK) Announces Achievement of Two Ebola Zaire Vaccine Candidate Milestones by Merck (MRK)

NewLink Genetics Corporation (Nasdaq: NLNK), announced today that Merck (NYSE: MRK) has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP).The U.S Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has provided the vaccine candidate PRIME (PRIority MEdicines) status.V920 was initially engineered by scientists from the Public Health Agency of Canada and subsequently licensed to NewLink Genetics.


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Merck Gets Breakthrough Therapy Status From FDA And PRIME Status From EMA For Investigational Ebola Zaire Vaccine - Merck & Company, Inc. (NYSE:MRK)

Merck Gets Breakthrough Therapy Status From FDA And PRIME Status From EMA For Investigational Ebola Zaire Vaccine - Merck & Company, Inc. (NYSE:MRK)

Merck & Co., Inc. (NYSE: MRK) revealed Monday about two regulatory milestones for its investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated).While the Food and Drug Administration has granted the vaccine candidate Breakthrough Therapy Status, the European Medicines Agency (EMA) has accorded PRIME (PRIority MEdicines) status.Merck said the FDA's Breakthrough Therapy Designation was planned to expedite the development, as well as review of a candidate that was planned for use, alone or in combination, to treat a serious or life-threatening disease.


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Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)

Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced two regulatory milestones for the company's investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status.The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.PRIME is an approach from the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need.