Worldwide attention by regulatory authorities on the contribution of genetic factors to drug response has increased. This is reflected by a developing regulatory framework that facilitates PGx integration into drug development such as Voluntary Exploratory Data Submissions in the USA and Japan, as well as the more recent, formal biomarker qualification by the regulators.

There are good reasons to worry about the prospect of adding drug reimportation provisions to health care overhaul legislation.

Patients who take a close look at medical science in search of treatments are often appalled by what they discover. On the one hand, there's academic research, a self-contained and self-absorbed universe of its own where data may be internally consistent (on a good day) and robustly reproducible, yet often has little relevance to real-world clinical conditions.

Today, URL Pharma was acquired by Takeda for nearly $800M.  The story here in brief is that for hundreds of years, colchicine was used for the treatment of gout and other conditions; it was an effective drug but had to be used carefully. URL invested in the formulation development and clinical studies required for colchicine, and ultimately received FDA approval in 2009. 

Developing new, effective drugs is staggeringly expensive, and the high prices of certain drugs on the market are directly related to this initial investment, according to a new AEI Press book.

While controversy has raged over the Food and Drug Administration's (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA's role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...

While controversy has raged over the Food and Drug Administration’s (FDA) handling of drug safety, a lower-profile but equally important debate has centered on the FDA’s role in the development and commercialization of the most innovative kinds of new drug treatments for cancer and other conditions that have long defied...