Merck's Ebola vaccine grabs FDA, EMA milestones in push toward licensure : fiercepharma

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Merck's Ebola vaccine grabs FDA, EMA milestones in push toward licensure

Merck's Ebola vaccine grabs FDA, EMA milestones in push toward licensure

While much of the world has moved on to the latest headline-grabbing outbreak in Zika, Merck continues to press on with its Ebola vaccine candidate.On Monday, the New Jersey pharma announced its rVSV-ZEBOV has won the FDA's Breakthrough Therapy Designation and the EMA's Priority Medicines status.With both designations, the vaccine is set to receive additional regulatory support in its push toward licensure thanks to promising clinical data and a potential to best current Ebola options.


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Merck Ebola vaccine wins speedier reviews by regulators

Merck Ebola vaccine wins speedier reviews by regulators

The quest to develop an Ebola vaccine took a small but significant step forward as regulators on both sides of the Atlantic agreed to conduct speedier reviews of a treatment being developed by Merck.The US Food and Drug Administration granted what is known as a breakthrough therapy designation for the Merck vaccine, a status reserved for medicines designed to treat a serious or life-threatening illness.At the same time, the European Medicines Agency granted the vaccine Prime status, which refers to a treatment targeting an unmet medical need.


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NewLink gains fast-track support for Ebola vaccine

NewLink gains fast-track support for Ebola vaccine

Ames-based biopharmaceutical company NewLink Genetics has secured fast-track priority from U.S. and European drug regulators for a potential Ebola vaccine.NewLink's V920 vaccine candidate, which is co-licensed with the Public Health Agency of Canada and Merck pharmaceuticals, was given Breakthrough Therapy Designation by the U.S. Food and Drug Administration and Priority Medicines status, or PRIME status, by the European Medicines Agency.Skip Irvine, director of adult vaccines and product supply pipeline at Merck, said the designations allow the three groups to file clinical data as it is collected rather than all at once.