The Billion Dollar REMS: Xenazine and the Value of Facing Regulatory Realities
Prestwick's Huntington's chorea therapy won FDA approval in August, triggering a flurry of deals valued at over $1 billion. Not bad for a 50-year-old drug expected to treat no more than 5,000 patients-and a powerful case study in how embracing the new regulatory realities can pay off.