Pharmalittle: FDA proposes more rigorous cancer drug trials for accelerated approval; insurers not covering obesity meds for kids

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But you knew this would happen, yes? After all, the world, such as it is, keeps spinning. So why not give it a nudge in a better direction with a piping hot cup of stimulation? Our choice today is an old standby — hazelnut cream. Please feel free to join us. Meanwhile, we have been busy foraging for items of interest, which we hope will ease your journey today. Have a wonderful day and, of course, do keep in touch. We appreciate insightful tips. …

The U.S. Food and Drug Administration proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates, Reuters tells us. The agency proposed that companies conduct randomized controlled trials in which patients receive either a therapy or another alternate treatment instead of trials that test the drug without a comparator, known as single-arm studies. The FDA suggested two approaches — one of conducting a randomized clinical trial before getting the accelerated nod and then again to confirm the benefits, and another of holding just one trial to seek the nod with long-term follow-up.

More than 14.4 million children in the U.S. have been diagnosed with obesity, but many insurers have not signed on to cover new treatments, citing their high prices and limited track records, The Washington Post explains. Several new medications are potential game-changers, but drug companies have priced them beyond the reach of most American families without insurance coverage. And only an estimated 30% to 40% of commercial health insurance plans and 19 Medicaid programs cover anti-obesity drugs at some level, despite recommendations by the American Academy of Pediatrics that the drugs be used in some children at risk of serious health problems.

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