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The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both. Read More
A review of legal databases was unable find any liability lawsuits against pharmaceutical companies related to four years’ worth of products used under expanded access, according to a study by FDA researchers. Read More
A coalition of state attorneys general suing opioid manufacturers has expanded the investigation of marketing and sales practices to include several branded painkiller manufacturers and drug distributors. Read More
The European Medicines Agency updated two guidelines on clinical trials for cardiovascular treatments in acute coronary syndrome and chronic heart failure, first adopted in 2000. Both guidelines are scheduled to take effect March 1, 2018. Read More
Pfizer is suing Johnson & Johnson over its contracts and rebate policies with insurers and hospitals, saying they are designed to block sales of a biosimilar for J&J’s blockbuster Remicade therapy. Read More
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Read More