In order to operate in New York, "Navigenics agreed to make certain concessions … by modifying the DTC portion of their business," a regulatory official from the NY Department of Health's Wardsworth Center said this week.
The most widely read articles in Pharmacogenomics Reporter in 2009 included stories on the American Civil Liberties Union's lawsuit against Myriad Genetics and other patent holders of BRCA mutations; the US Food and Drug Administration's labeling updates to the anti-platelet agent Plavix, as well as the colorectal cancer drugs Erbitux and Vectibix; the growth of direct-to-consumer genomics services, such as 23andMe and Navigenics; Myriad's position on genetic counseling; and big pharma's reasons for investing in personalized medicine.
Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.
A changing R&D paradigm fueled by the growing demand for personalized medicine is "one of the reasons that the pharmaceutical industry is facing rising taxes," a PricewaterhouseCoopers expert said. As a result, a PwC report released earlier this month advised pharma, biotech, and device firms to invest in tax planning early in their business strategic decisions.