A product liability lawsuit is arguing that SmithKline Beecham's LYMErix vaccine should be used only in patients that have been tested for sensitivity to the outer surface protein A Lyme disease vaccine.
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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
