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Dako's HER-2 tests may be used as companion diagnostics for Herceptin in treating stomach cancer.

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.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.