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Rare Disease

Rare Disease New Developments

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  • 03 Jun
As a follow-up to my previous blog post on rare disease development in the pharmaceutical and biotech industry, here's a chart to show the increase in interest in applications since 1983, which was taken from the FDA website.
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Growing Interest in Rare Disease for Pharma and Biotech Industry

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  • 01 Jun
At BioClinica, we are involved in a number of rare disease studies. This is a growing area of development for the pharmaceutical and biotech industry. FDA’s office of Orphan Product Development reports that they saw a record 323 orphan drug designation requests come through the door in 2010. It's unclear why – one reason could be OOPD's outreach efforts. Rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in Europe. It is estimated that in the United States, 47% of rare disorders affect fewer than 25,000 people. Because patient populations for rare diseases are so small, big pharmaceutical companies historically have had little financial incentive to invest in drug development for these diseases.
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