Topic: Orphan Drugs

Debunking the Instant Myth of FDA as Rubber Stamp

FDA’s high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here’s the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of… Read more »

New White Paper: Top 10 Clinical Development Trends for 2015

With Q4 2014 upon us, it is time to gear up for 2015. A few things are clear. Clinical development will continue to evolve against a pattern of high-failure rates for products aimed at large populations and higher success rates for targeted therapies. Orphan Drug development will remain an area of intense activity with continued… Read more »