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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
With the clinical trials industry facing its lowest rates of recruitment and retention, drug developers must incorporate big data and patient voices to improve trial efficiency and hasten innovation, says a new report by the Tufts Center for the Study of Drug Development. Read More
The road to grabbing the title of FDA commissioner keeps getting tougher for Robert Califf, with Sen. Bernie Sanders (I-Vt.) becoming the latest lawmaker to place a hold on his nomination. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
Beginning April 1, innovative drugmakers participating in the Medicaid rebate program can expect to see their returns shrink 8 percent, under a final rule from the Centers for Medicare & Medicaid Services. Read More