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As confirmed cases of 2019-nCoV coronavirus topped 28,000 this week with 500 fatalities, two senators urged FDA Commissioner Stephen Hahn to ensure that drugs, devices and food imported from China remain safe during the coronavirus outbreak. Read More
As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance yesterday on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product. Read More
The FDA cited Sunstar for serious violations at a manufacturing facility in China, issuing the firm a warning letter for failing to test incoming drug components and finished products, among other violations. Read More
In comments to the FDA, multiple drugmakers urged the agency to expand the scope of its planned pilot for reviewing novel excipients outside of drug applications. Read More
The Patent Trial and Appeal Board sided with Biogen in Mylan’s patent challenge over Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate). Read More
In his State of the Union address last night, President Trump called on Congress to pass legislation to curb the nation’s high drug prices, saying he would sign a bipartisan bill into law if it reached the Oval Office. He did not mention insulin pricing as expected. Read More