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Janssen Seeking Medicare Add-On Payments For CAR-T Carvykti, But CMS May Be Skeptical

J&J will need to convince the Centers for Medicare and Medicaid Services that its treatment is not substantially similar to existing CAR-T’s in order to qualify for supplemental Medicare reimbursement.

Medicare Reimbursement

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After the boom of 2020 and 2021, the biotech sector is experiencing one of the deepest and longest downturns but there are hopes that catalysts could soon revive confidence.

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Gene Therapy Reviews Return To US FDA Advisory Committee Schedule

The upcoming review of two novel gene therapies from bluebird bio marks will be the first time the US FDA’s CTGTAC has met for a genetic product review in five years. That is a surprisingly long gap – and one that probably will not be repeated.

Gene Therapy Advisory Committees
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