Phase I
Three genome editing companies, Intellia Therapeutics, Editas Medicine and uniQure, are each anticipating a bright 2022 as the promises of gene therapy continue to be realized.
More biotech companies turn to private investors as the market churns volatile for life sciences. Here’s who’s scooping up the cash this week.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
The FDA asked Homology Medicines to modify the pheNIX gene therapy trial’s risk mitigation measures to prevent any serious issues that may arise.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Clinical Catch-Up for February 21
Patient enrollment for the clinical trial, which was testing Atara’s autologous chimeric antigen receptor (CAR) T-cell immunology therapy called ATA2271, has been paused.
Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.
Biopharma and life sciences companies from across the globe provide updates to their pipelines and businesses.
The FDA sent an email holding the planned Phase I trial for LB1901 after the first and only patient dosed was found to have low CD4+ T-cell counts in the peripheral blood.
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