New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.
In a rallying cry for gene therapy, FDA Commissioner Scott Gottlieb says he’s determined to clear the pathway for drug developers in a move to accelerate the first wave of gene therapies pointed to the market.
The FDA will soon release a series of guidance documents that it hopes will speed development of the already rapidly growing world of gene therapies, according to Commissioner Scott Gottlieb.
Members of the Alliance for Regenerative Medicine are in town, too, talking with lawmakers about gene therapy, cell therapy and tissue engineering. They’re meeting with dozens of congressional offices.
This article discusses 25 gene-therapy candidates that have reached Phase III and/or registrational trials as of Q1 2018.
In this podcast and accompanying we interviewed Dr. Robert Preti about the past, present and future of global cell therapy manufacturing.
An alliance with outcomes measurement body ICHOM intends to accelerate the push towards value-based care. The aim is to square the circle between the budget squeeze facing healthcare systems and paying for medical innovation coming through the pipeline.
