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The war of words between managed care and pharmaceutical manufacturers, which began when Gilead set the price for its drug to treat the hepatitis C virus (HCV), has taken off in October with the reclassification of a trio of cancer drugs from Genentech. Growth in the "specialty pharma" sector, where prices are rising much faster than drug prices generally, has drawn concern from payers and the umbrella group that represents them, while the trade group that represents drugmakers is pushing back against critics, saying that it faces challenges in bringing life-saving therapies to market.

Recently approved as second-line treatment of metastatic melanoma, following resistance to ipilimumab, the FDA has now designated Keytruda as breakthrough therapy to treat EGFR-mutation and ALK-rearrangement negative NSCLC patients who have pr0gressed following platinum-based therapy.

Today, Merck announced that Keytruda has been granted breakthrough therapy designation for treating patients with epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangement-negative non-small cell lung cancer (NSCLC).

The group, led by Koch Institute director Tyler Jacks, used CRISPR to generate mutant genes that were then packaged into enteroviruses that were used to infect target organs in mice. This is a much faster process than the traditional method that need crossing genetically-engineered mice.

Taiho Oncology, Inc, announced that the FDA granted Fast Track designation for an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer.

The non-invasive nature of the test makes it a very attractive alternative to the uncomfortable colonoscopy used to detect colorectal cancer. In a New England Journal of Medicine study of 10,000 patients, the test identified 92% of colorectal cancers in average-risk patients and 42% of polyps.

While the current approved immuno-oncolgy drugs have been approved for melanoma, Roche has also been evaluating their new molecule in triple-negative breast cancer. The results will be presented at the San Antonio Breast Cancer Symposium.

Fewer than 15% of physicians routinely recommend HPV vaccination to male patients, according to the study published in the journal Cancer Epidemiology, Biomarkers & Prevention.

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