A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient,…

The future of the pharmaceutical industry will involve increased use of master protocols, trial platforms and clinical-trial networks, said CDER director Janet Woodcock this week at a National Academies of…

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…

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…

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. Source: Drug Industry…

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…

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…

The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Source: Drug Industry Daily

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: Drug Industry Daily

An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. Source: Drug Industry Daily