Emmaus and Mitsubishi Tanabe Refuse To Take EU Approval Blows Quietly
Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.
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Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe
It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.
Divergences between the EU and US agencies in marketing application approval decisions in 2014-2016 were primarily due to differences in the regulators’ conclusions about efficacy based on review of the same data or to differing clinical data submitted to support the application, a study has revealed.