In 2019, 44% of novel drugs approved in the U.S were classified with orphan designation. 60% of approved drugs fell into one or more expedited categories: Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval. But how does public concern over increasingly high drug prices impact patients in need of newly available, life-altering medications? Does the political environment and legislation influence your business strategy? Clinical stage companies must begin developing commercial strategies as early as Phase II to effectively meet these concerns and chart a course for a successful product launch. We invite rare orphan and specialty biopharma manufacturers to contact joff@dilig
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