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The parents of twin girls with a rare genetic disorder sued a drugmaker and therapy accelerator for misappropriating the children’s trial data to secure a breakthrough therapy designation. Read More
A Michigan clinic manager pleaded guilty to a scheme to unnecessarily prescribe controlled substances that lost Medicare $131 million, and Attorney General Jeff Sessions called the plea the latest victory in Justice Department efforts against those exploiting the opioid addiction epidemic. Read More
A charity that helps low-income patients buy prescription drugs sued the federal government, claiming federal overreach left it unable to communicate with donors. Read More
The U.S. Court of Appeals for the Federal Circuit found that a district court was overly broad in its interpretation of patents in a lawsuit by a Teva subsidiary accusing Apotex of infringing its patents for the coating on a muscle relaxant pill. Read More
A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin. Read More