Noted

Concluding that “the transaction is no longer in the best interests of stockholders at the agreed upon valuation,” AbbVie's Board of Directors has withdrawn its support for a proposed merger with the biopharmaceutical company Shire. The decision was spurred by a U.S. Treasury notice regarding the tax implications of such a transaction. AbbVie will pay Shire a “break fee” of $1.635 billion.

The NCI launched the Exceptional Responders Initiative, a study that will investigate the molecular factors associated with dramatic responses to cancer treatment relative to responses in other patients receiving the same therapy. Researchers plan to examine tissue and clinical data and conduct gene sequencing in as many as 300 cases.

The Indiana University Melvin and Bren Simon Cancer Center in Indianapolis has once again been recognized as an NCI-designated cancer center. The designation will bring $7.8 million in federal grant money to the institution over the next 5 years, an increase of 20% from its previous award in 2008.

To help speed the development and approval of drugs for certain breast cancers, the FDA released a guidance document for industry called “Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval,” which defines pathological complete response, discusses endpoints for neoadjuvant trials, and identifies suitable patient populations. However, the agency acknowledges that “important regulatory questions remain.”

New Canadian guidelines recommend against using the prostate-specific antigen test to screen for prostate cancer based on evidence showing an increased risk of harm, such as false-positive results and unnecessary treatment, and little evidence of reduced mortality. The guidelines, published in the Canadian Medical Association Journal, are consistent with the recommendations of the U.S. Preventive Services Task Force and Cancer Council Australia; the UK does not have an organized screening program (CMAJ 2014;186:1225–34).