Roche is buying US-based gene therapy specialist Spark Therapeutics for $4.3 billion (€3.78 billion) after developments in this area convinced the Swiss drugmaker to "step up", chief executive Severin ...
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways ...
Until recently, even the most advanced gene therapies could only be given after a child was born—often racing against time to prevent irreversible damage. In the first part of this series, we explored ...
As newborn screening and rapid DNA sequencing become routine, we are poised to catch and treat inherited diseases at their earliest stages. Today, we can intervene in the first days or weeks of life.
Both community and academic delivery models play essential and complementary roles in expanding CGT access. Over the past decade, cell and gene therapies (CGTs) have evolved from promising theoretical ...
How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of ...
Alison Clare has received funding from the Wellcome Trust and the Medical Research Council. Her position is currently funded by National Institute for Health and Care Research (NIHR) Biomedical ...
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting ...
The cancer gene therapy market's growth is propelled by rising R&D investments, increasing cancer incidence, and supportive ...
Matica Biotechnology, Inc., a U.S.-based Contract Development and Manufacturing Organization (CDMO) specializing in cell and ...
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