Clinical research
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
Synairgen watched its stock plummet 85% after reporting disappointing Phase III results for its inhaled COVID-19 treatment on Feb. 21.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
AstraZeneca and Daiichi Sankyo released positive data from their Phase III trial of Enhertu. An alternative to chemotherapy for some HER2 low breast cancer.
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.
After roaring into February with positive data in five different indications, Regeneron and Sanofi announced today a late-stage Dupixent trial has been halted due to futility.
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.
PRESS RELEASES
