Efficacy standard an elusive goal

If anything has become clear in the past year or so, it is just how tough it is to prove efficacy in many of the diseases being targeted by biotech drugs.

One of those areas is rheumatoid arthritis. Following the receipt last week by Greenwich Pharmaceuticals Inc. of a "not approvable" letter from the FDA for Therafectin, BioCentury surveyed other companies in the clinic with RA drugs to elucidate the issues in RA trials and how companies are coping with them. ...