Building a Business in Drug Safety
This article was originally published in RPM Report
Executive Summary
Marketing a portfolio of high-risk drugs is a precarious proposition but Celgene Corp.has turned it into a profitable business model. Extreme risk management is not for everyone: it works best for high-price specialty products. Celgene has two products under risk management programs: thalidomide (Thalomid) and lenalidomide (Revlimid). Amylin Pharmaceuticals Inc. and Intarcia Therapeutics Inc. are also interested in risk management programs.
You may also be interested in...
Safety Panic: Tysabri, Byetta and the Challenge of Risk Communication on Wall Street
There is no question someone is over-reacting to safety issues with Biogen Idec/Elan's Tysabri and Lilly/Amylin's Byetta. But is it FDA-or investors?
Safety Panic: Tysabri, Byetta and the Challenge of Risk Communication on Wall Street
There is no question someone is over-reacting to safety issues with Biogen Idec/Elan's Tysabri and Lilly/Amylin's Byetta. But is it FDA-or investors?
The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools
Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.