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Vertex is likely to have the cystic fibrosis market to itself for years to come, but investors are banking on it repeating that success in several new first-in-class therapy areas.
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.
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.
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.