The FDA approved Amyvid for Alzheimer´s testing in April 2012, yet Medicare and Medicaid denied coverage for it last July. The new brain imaging drug helps detect beta-amyloid neuritic plaques in the brain, which are associated with Alzheimer´s disease. In the past, in order to detect these plaques, a biopsy had to be performed. But the test remains controversial -- will it be taken up?
Drug discovery is the process by which novel therapeutic candidates are discovered and ultimately developed into human-grade medications. These candidates may include compounds ranging from modified or unmodified natural products or extracts and small molecules to biologics. Forbes reports that the average cost of drug development for a major pharmaceutical company is between $4 billion and $11 billion, which is a great deal higher than the more commonly reported $1 billion, as it accounts for failure rates. And in fact, failure rates are an important part of the drug discovery process.
The Mayo Clinic and Acorda recently enrolled the first patient in their phase 1 clinical trial of a remyelinating antibody that may potentially reverse the damage caused by multiple sclerosis. I recently interviewed Anthony O. Caggiano, MD, PhD, Vice President of Research & Development at Acorda since February 2009. Since joining Acorda in 2001, he has served in various roles in preclinical science and research and development, directing basic research and product development efforts, coordinating external research programs with academic and commercial partners, and collaborating in business development activities.
As the fourth leading cause of death in the U.S. and a leading cause of permanent disability, stroke has an incredible impact at both the individual and economic level. According to the CDC, an American dies every 4 minutes as the result of an acute stroke. With 87% of these strokes being ischemic in nature, rapid assessment and diagnosis of patients with stroke symptoms is required in order to ensure that eligible patients receive fibrinolytic therapy within the recommended time frame (around 3 hours). Research has shown that although healthcare providers in the inpatient setting are greatly reducing delays to treatment, there is still much work to be done in the pre-hospital setting to ensure that valuable time is not lost.