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Latest From CellTrans, Inc.

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

CellTrans’ Donislecel Gets US FDA Panel Nod For Small Group Of Type 1 Diabetics

Benefits of independence from exogenous insulin outweighed the risks from long-term immunosuppression necessary with the allogeneic pancreatic islet cellular therapy, majority of panelists said, but they urged the FDA to limit the indication to a very small subpopulation of patients.

Advisory Committees Drug Review

CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes

Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.

Advisory Committees Regenerative Medicine

Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals Biosimilars
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