STAT+: Pharmalittle: FDA decision on Novavax Covid shot could be delayed; new drug prices rose 20% annually in recent years

Good morning, everyone, and how are you today? We are doing just fine, thank you, as we wind up a quick sojourn to the global STAT headquarters — also known as the Pharmalot campus away from home — for a retreat, of sorts. This had made it challenging, though, to indulge some of our usual routines, but we remain vigilant as we forage for truly worthy cups of stimulation. Not just any old cup of stimulation will do, after all. Meanwhile, as we prowl about, we are happy to pass along the latest collection of interesting items. We hope you have a wonderful day and, as always, encourage you to stay in touch. …

The U.S. Food and Drug Administration needs to review changes to the manufacturing process used by Novavax before it can authorize the company’s Covid-19 vaccine, CNBC reports. An FDA committee of independent vaccine experts on Tuesday voted overwhelmingly to recommend the vaccine for use in the U.S., after an all-day meeting in which they reviewed data on safety and its effectiveness at preventing Covid. The FDA says Novavax informed the agency of changes to its manufacturing process on June 3, days before the committee was scheduled to review the safety and efficacy data.

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