Month: January 2017

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. In…

In this post, intended for a general audience, I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the “505(b)(2) regulatory pathway”. What are 505(b)(2) new drug…

With 2017 upon us, many Alzheimer’s Disease (AD) stakeholders may look back at the year that was with a sense of dismay, given the failure of several important clinical trials aimed at translating putative mechanisms into FDA approved drugs. In this brief year-in-review, I say despair not.  First, you could be suffering the January blues.…