Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing perifosine, a novel, potentially first-in-class, oral anti-cancer agent that inhibits key signal transduction pathways, which are associated with programmed cell death, cell growth, cell differentiation and cell survival. Perifosine is currently in Phase III clinical development for both refractory advanced colorectal cancer and multiple myeloma.
"Obama's order will require the FDA to expand reporting on potential drug shortages, accelerate review of new drug applications, manufacture scarce meds more efficiently, and share more information with the Justice Department to help fight price gouging, The New York Times reports. Similar provisions are part of legislation that's been lagging in Congress since February 2011."
He noted that "in 2010, there were 178 shortages reported by the FDA with confirmed cases of patients dying, in part because of shortages of potential new and innovative life-saving drugs, also known as 'orphan drugs.' " The order will work "to get orphan designated drugs approved faster, with less stringency," which may serve to increase Perifosine's chances to getting FDA approval.