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Wyeth vaccine fast-tracked by FDA
30 May 2008
Medical Information
Wyeth's new pneumococcal conjugate vaccine, designed for babies and toddlers, is being fast-tracked by the US Food and Drug Administration (FDA).
Emilio Emini, executive vice-president of vaccine research and development with the organisation, said he is "very pleased" with the move.
"While the incidence of pneumococcal disease has been substantially reduced since our introduction of PREVNAR in the United States, pneumococcal disease remains a health threat to children," he explained.
In particular, emerging strains like 19A are becoming more prevalent, Dr Emini added.
Fast-track decisions are made by the FDA in cases where a product may treat serious conditions which are currently not provided for by existing medicines.
Earlier this month, RTT News reported that Wyeth Pharmaceuticals had received an approval from the FDA for its bazedoxifene drug, which treats postmenopausal osteoporosis.
This follows the FDA requesting further analyses of the incidences of strokes and venous thrombotic when the organisation made its new drug application in December last year.
