Orphan Drugs May Grow More Common As Medicine Becomes More Personal
As drug research increasingly focuses on identifying patients who will most benefit from a given therapy, more drugs will qualify for orphan status and companies will be able to take advantage of the economic incentives to develop those drugs
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FDA's new authority to require post-market studies under the FDA Amendments Act could be the ticket to approval for Amgen's platelet producer Nplate (romiplostim)
Provisions in the House version of the FDA user fee bill would raise the cut-off for an orphan drug to qualify for a user fee waiver from firms with less than $10 million in annual revenue to firms with less then $100 million
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.