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The FDA updated the labeling for warfarin on Jan. 22 to include PGx-guided dosing ranges. FDA's Lesko explained that the labeling provides dosing ranges in order to give doctors the flexibility to consider their patients clinical factors when determining the appropriate maintenance dose of the anticoagulant.

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paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance.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.

According to one of the world's largest professional services firms, the trend toward tailoring drugs based on clinical factors and genomic variation will create opportunities and challenges for the pharmaceutical and biotech industries. PricewaterhouseCoopers estimates that the market for "a more personalized approach to health and wellness will grow to as much as $452 billion by 2015."

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

BMS will continue to use Asterand's tissue-based drug-discovery products and services for up to three years.

Although this update is only for Plavix, the FDA is mulling whether to update the labeling for CYP2C19-inhibiting drugs, and is looking at whether drug response is compromised in all patients or only those with certain CYP2C19 mutations.

This week's labeling change follows an earlier update from the agency informing healthcare providers of studies indicating poor CYP2C19 metabolizers have limited response to Plavix.

Medco's study will examine whether the 70 to 75 percent of patients who are "extensive metabolizers" of Bristol-Myers Squibb's Plavix will have "comparable outcomes" to patients taking Eli Lilly's more expensive Effient.

Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.

"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.

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The Los Angeles Times reports that experts say Moderna's investigational COVID-19 vaccine results seem to be a step in the right direction, but that more testing is needed.

The Washington Post reports a new coronavirus data reporting protocol goes around the Centers for Disease Control and Prevention.

The Trump Administration has reversed its policy that could have stripped international students of their visas, the New York Times says.

In Cell this week: proteomic and metabolomic analysis of blood from COVID-19 patients, change in phosphorylation with infection, and more.