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In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.

The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.

At a March meeting with industry groups, the FDA gathered comments regarding the barriers to drug/diagnostic codevelopment and noted the agency might issue a series of white papers on the topic.

The company also released its fourth-quarter financial results, posting higher losses on increased research and development spending as it worked to move its first drug into the clinic this year.

The FDA has confirmed to DxS that its TheraScreen KRAS test is a Class III device. The company is in the process of submitting its premarket approval application to the agency.

The International Brotherhood of Electrical Workers launched its Stop Biotech Looting campaign last week after learning that subcontractors have been hiring non-union workers over the past year on a half-dozen projects for Boston-area life-sci giants.

The Massachusetts Life Sciences Center has approved spending a combined $2.5 million of the $1 billion, 10-year Life Sciences Act to subsidize life-sci companies that hire paid college-level interns, and to fund younger researchers.

Imperial College London and its spinout DNA Electronics have created a prototype for the so-called SNP Dr., which is being developed under a £1.2 million project that also includes Pfizer.

NHLBI plans to launch next month the prospectively designed, randomized-controlled study, called Clarification of Optimal Anticoagulation through Genetics trial, which will follow 1,200 patients to see if PGx-guided dosing is clinically useful.

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A Harvard University professor has been charged with making false claims regarding funds he received from China, the New York Times reports.

Discover magazine reports that animal dissections might dissuade students from science careers, but that a firm has developed synthetic frogs for dissections.

Nature News reports that a US panel is reviewing current guidelines for federally funded gain-of-function viral research.

In PNAS this week: de novo mutation patterns among the Amish, an alternative RNA-seq method, and more.