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With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of clinical tools gathered together under a new pilot program. Read More
Biosimilar developers can expect the FDA to demand costly clinical trials to verify that a biosimilar is effectively identical with a reference product. Read More
Titan Pharmaceuticals yesterday won positive news from an FDA advisory committee, with panelists voting in favor of approving its implant to treat opioid addictions. Read More
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