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A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs. Read More
A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical released Tuesday outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More
While 2014 and 2015 were years of megamergers in the pharmaceutical industry, a new report predicts that 2016 will give rise to a rather different competitive landscape, one where bigger is not necessarily better. Read More
Three stem cell treatment centers owned by the same physician have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
A European Parliament committee is calling into question the safety of a pilot adaptive licensing pathway that would bypass traditional approval processes by the European Medicines Agency. Read More
The U.S. Supreme Court delivered Janssen a stinging rebuke on Monday, declining to hear its appeal of a $124 million penalty ordered by the Supreme Court of South Carolina over claims of deceptive advertising. Read More