Planning for a New Era: Commercial Strategy under the Lens of Public Scrutiny
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 de
