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At a luncheon hosted by the Personalized Medicine Coalition last week, FDA Commissioner Margaret Hamburg said the agency will release its drug/diagnostic codevelopment guidance this year, and discussed how personalized medicine can be advanced through a new NIH/FDA partnership.

Pharmacy-benefits manager Medco this week outlined some activities planned for the Medco Research Institute, which is spearheading the company's pharmacogenomics research efforts. Additionally, during the company's 2009 earnings call, officials discussed the acquisition of DNA Direct and the forthcoming release of results from a study looking at PGx-guided warfarin dosing.

A new NIH-FDA leadership council and grant program will support ways to use regulatory science to advance translational medicine.

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

The designation allows for possible research and development incentives, and qualifies the company for tax credits and a period of market exclusivity following market approval.

DxS denies allegations in a lawsuit filed by Roche last week that the UK-based diagnostics company is trying to renege on a distribution agreement between the two firms for KRAS and EGFR mutations tests.

The Caris Registry will contain information about cancer patients using the company's Target Now suite of molecular profiling services, including the genetic profile of patients' tumors, their cancer treatment history, and their clinical outcome.

Responding to an HHS committee's request for comment on its educational and marketing practices, Myriad maintained that urging doctors to conduct genetic counseling in house instead of referring patients to a genetic counselor is legally sound, follows professional medical societies' standards, and accommodates the shortage of cancer genetics professionals.

A Novartis spokesperson told Pharmacogenomics Reporter last week that the company "plans to have discussions with the FDA about the specific requirements for the approval of lumiracoxib when used in conjunction with a biomarker program."

Although FDA is still practicing regulatory enforcement discretion for the majority of laboratory-developed tests, the agency will put in place mechanisms allowing voluntary reporting of adverse events and malfunctions associated with LDTs through its MedWatch system.

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President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.