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Congress voted Monday afternoon to re-open the government after failing to pass a stopgap measure over the weekend, which shut down federal agencies — but concerns remain about an upcoming standoff and the possibility of another shutdown in February. Read More
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More
Merck and Glenmark engaged in anticompetitive behavior by keeping a generic version of Zetia off the market, creating a monopoly and manipulating the drug price, according to a newly filed lawsuit seeking class action status in a Virginia federal court. Read More
Janssen filed suit in a federal court against Teva last week alleging patent infringement of its schizophrenia drug Invega Sustanna — a product that brought in more than $2 billion in 2016. Read More
CDER published an agenda of 98 upcoming draft guidances for the 2018 calendar year — including new recommendations for developing treatments for Alzheimer’s and amyotrophic lateral sclerosis. Read More