Merck & Co., Inc. (MRK) Joins Novo Nordisk A/S (NVO) to Reassure Safety of Diabetes Drugs
6/12/2013 7:52:20 AM
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Merck & Co. (MRK), Novo Nordisk A/S (NOVOB) and other makers of diabetes treatments may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.
The Food and Drug Administration said it’s considering setting up a study, either through the agency or the companies, that looks deeper into whether drugs for Type 2 diabetes, including Byetta from Bristol Myers-Squibb Co., cause pancreatic cell growth that could turn cancerous. One option is a large clinical trial designed to show patterns of adverse events, said Morgan Liscinsky, an FDA spokeswoman.
A debate swirled in the medical community in March with talk of unpublished findings that the FDA said may show pre-cancerous cellular changes in diabetics taking drugs called incretin mimetics. The FDA is reviewing the data and scientists from the agency and the companies are gathering today at the National Institutes of Health to sort it out.
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