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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 UK’s healthcare cost watchdog has issued a final guidance that will reimburse seven biologicals as options for treating severe rheumatoid arthritis in patients who have not responded to conventional treatments. 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