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One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to unnaturally extend the life of another medication. Read More
The UK’s reimbursement watchdog has given its blessing to five treatments — four for cancer and one for a lung disease — recommending they be funded by the National Health Service, while frowning on Lilly’s stomach cancer drug. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More
The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted pharmacies in Pennsylvania, Massachusetts and Texas with Form 483s for inadequate sterilization practices. Read More
The FDA is planning an assortment of activities in 2016 to push for greater diversity in clinical trials, says Robert Califf, the presidential nominee to head the agency. Read More