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FDA reviewers expressed strong concerns over the possibility of liver damage related to solithromycin treatment ahead of an advisory committee meeting Friday on whether the drug should be approved as an antibiotic for community-acquired bacterial pneumonia. Read More
A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and backdating records. Read More
The formal process for disputing a patent before the U.S. Patent and Trademark Office skirts statutory requirements and provides drugmakers with an unfair proceeding that skews outcomes, industry said. Read More
A federal judge in New Jersey has ruled that Merck’s patent infringement lawsuit against generic drug manufacturer Fresenius Kabi can proceed. Read More
Endo Pharmaceuticals is pushing to keep alive a lawsuit against it by the Federal Trade Commission in the U.S. District Court for the Eastern District of Pennsylvania. Read More