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The state of Kentucky has filed a lawsuit against Teva, alleging the drugmaker’s off-label promotion of two drugs for cancer pain has exacerbated the opioid epidemic. Read More
Abbott Laboratories and AbbVie reached a $25 million settlement with the federal government, which charged the companies violated the False Claims Act to promote sales of the drug TriCor (fenofibrate). Read More
Arkansas Attorney General Leslie Rutledge petitioned the Supreme Court to uphold a state law that requires PBMs to reimburse pharmacies after they dispense drugs to patients at wholesale inventory costs. Read More
The FDA released a draft International Council for Harmonisation guideline explaining how sponsors can waive in vivo bioequivalence clinical trials using the Biopharmaceutics Classification System (BCS). Read More
Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility. Read More
For the second time, a federal court dismissed a nonprofit’s lawsuit seeking to compel the FDA to amend its informed consent rules for clinical trials. Read More