EU regulators shut out new Gaucher drug from Pfizer, Protalix

Just weeks after winning U.S. approval for their new Gaucher drug taliglucerase alfa, the EMA's Committee for Medicinal Products for Human Use says Pfizer ($PFE) and Protalix BioTherapeutics should be shut out of the EU in order to honor Shire's exclusive status for its currently used Vpriv. The regulators overlooked the developers' argument in favor of an exemption, noting that their drug was not demonstrably better than Vpriv and no shortage exists that demands a remedy. The EC generally takes the advice it's given on these issues, so Pfizer and Protalix may have to settle for their big win in the U.S. Story

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