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Rare Diseases are Not so Rare

Mar 7, 2018 4:00:46 PM / by John Kouten, CEO posted in digital communications, digital marketing, life science marketing, rare diseases, orphan drugs, life science PR, life science communications

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JFK Communications attended the sixth annual Rare Disease Day in Trenton.  This critical event was convened to draw attention to the need for greater awareness of, and investment in, rare disease treatments.

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Scott Gottlieb, MD and the Orphan Drug Modernization Act

Sep 28, 2017 11:51:37 AM / by John Kouten, CEO posted in FDA, rare diseases, orphan drugs

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Scott Gottlieb, MD, appointed as FDA commissioner in May 2017, has made some fast progress. According to the FDA Voice, The FDA has reviewed the backlog of orphan designation requests that were more than 120 days old. And they accomplished this goal on August 28, 2017 – nearly a month ahead of their September 21 deadline.

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Top Three Challenges Facing Orphan Drug Candidates

May 17, 2017 9:00:00 AM / by John Kouten, CEO posted in drug development, rare diseases, orphan drugs, Precision medicine, FDA approval process

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Prior to the passage of the 1983 Orphan Drug Act, just 34 drugs were approved to treat rare diseases, leaving small patients populations with few options for their rare diseases. That number has since skyrocketed with the implementation of the Orphan Drug Act. In 2016 alone, the FDA designated 333 drugs in development as orphans and approved 39 products, including both novel medicines and new orphan uses of approved drugs. Since the Orphan Drug Act took effect, The FDA has designated 3,600 orphan drugs and approved 552 orphan drugs.
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