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Kermani F – More than 50 million people in the EU and US alone suffer from rare diseases. The reluctance of drug manufacturers to commit R and D spend on these areas because of the low level of return, coupled with intense lobbying efforts of patient groups, has caused many regulatory agencies to introduce initiatives that have incentivized rare disease R and D. The number of drug approvals for rare disease has escalated since the implementation of these regulations, and the EU and US have now joined forces to improve the..

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