STAT+: Pharmalittle: Lilly and Eisai will still seek accelerated approval for Alzheimer’s drugs; CAR-T cells may shrink some solid tumors

Eisai and Eli Lilly still plan to seek accelerated approval for Alzheimer's drugs even after CMS severely limited coverage of medicines approved under the controversial program.

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because — you guessed it — that oh-so familiar routine of deadlines, online calls, and meetings has predictably returned. To cope, we are firing up the coffee kettle to brew several cups of stimulation. Our choice today is vanilla macadamia nut. As always, you are more than welcome to join us. Meanwhile, here is the latest menu of tidbits to help you as you start your own journey today. We hope the day is meaningful and productive. And do stay in touch. We appreciate feedback and tips. …

Eisai and Eli Lilly still plan to seek accelerated approval for experimental Alzheimer’s drugs even after the Centers for Medicare & Medicaid Services decided to severely limit coverage of medicines approved under the controversial program, Reuters writes. On Thursday, CMS decided it would only pay for a Biogen Alzheimer’s treatment, and other drugs that work in a similar fashion, for patients enrolled in valid clinical studies, unless the treatments demonstrate clear evidence of patient benefit. The two drugmakers said they expect upcoming Phase 3 trial results to eventually validate earlier-stage data under review by the U.S. Food and Drug Administration.

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