EML4/ALK fusion | GenomeWeb

EML4/ALK fusion

Pfizer completed submission of its NDA for the ALK-inhibiting non-small cell lung cancer drug crizotinib, and was granted a priority review from the FDA. Meantime, Abbott Molecular plans to submit "shortly" a premarket approval application for a commercial companion diagnostic that will pick out best responders to crizotinib.

The drug/diagnostic codevelopment partners are each planning to complete regulatory submissions with the FDA in the first half of this year for a pharmacogenomic NSCLC treatment targeting patients with the EML4-ALK-fusion oncogene.

The Wall Street Journal reports that National Institutes of Health Director Francis Collins' response to contamination concerns at the agency might have delayed care.

The final revision of the Common Rule doesn't include the proposed change requiring consent for leftover biospecimens.

The first Reproducibility Project: Cancer Biology papers show mixed results.

In Nature this week: mobile phone-based targeted DNA sequencing, and more.