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Novartis is developing a companion diagnostic for Prexige and is evaluating its submission strategy for the painkiller with health regulators around the world. Can the Swiss drug giant use pharmacogenomics to resurrect a drug that already bears the stigma of being rejected by the FDA for liver safety concerns?

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.

GSK and Abbott will develop a companion diagnostic for GSK's investigational MAGE-A3 immunotherapy. After discussions with the FDA, GSK believes the drug and diagnostic will be reviewed simultaneously, and labeling language for the drug will require genetic testing prior to treatment.

The director of CDC's Office of Public Health Genomics detailed GAPPNet's plans to close the hole in translational research and discussed how "the stars are aligning" in healthcare reform to further drive the integration of genomics and personalized medicine into clinical practice.

Accera presented data at the International Conference on Alzheimer's Disease this week in Vienna, showing that the ketogenic compound Axona "demonstrated significant improvement" in patients who lacked the epsilon 4 variant of the APOE gene and the C/C polymorphism in IDE 7.

The FDA cleared Cepheid's C. difficile test to run on its GeneXpert System. The firm expects to begin shipments next week.

The bill would increase funding for food safety and agricultural and drug research.

The genotyping test has been cleared for use on the company’s eSensor XT-8 system.

A federal council's recognition of the role of studying patient subgroups in comparative effectiveness research increases the chance that personalized medicine initiatives will be a key feature of healthcare reform, government officials and industry observers said.

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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.