Jul 9, 2021 | Clinical Trials, Healthcare, Innovation, Medical Translation, Pharmaceuticals, Regulatory
On our most recent Coffee & Conversations podcast episode, podcast hosts Brigid and Shelby joined CSOFT’s President and CEO Shunee Yee and Professor Victoria Elegant, who serves as Vice-President of JAPAC Regional Medical Head of Amgen to discuss The Next...
Feb 3, 2021 | Clinical Trials, FDA, News, Regulatory
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
Oct 12, 2020 | News, Regulatory
The U.S. Food and Drug Administration (FDA) Advisory Committee voted 16-1 in favor of passing Alkermes’ schizophrenia and bipolar disorder treatment drug (AKMS 3831). FDA members voiced concern about the potentially addictive qualities of the drug, as it contains an...
Oct 2, 2020 | Classification System, News, Regulatory
Today (10/2) the U.S. Food and Drug Administration (FDA) announced the rejection of Ryoncil, a treatment for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients. For patients with the most aggressive form of SR-aGVHD, the mortality rate...
Aug 28, 2020 | News, Regulatory
Laurent Pharmaceuticals, a Montreal based clinical stage biopharmaceutical company has come up with an oral drug candidate, LAU-7b, to potentially treat COVID-19. The U.S. Food and Drug Administration (FDA) has granted Laurent Pharmaceuticals to begin enrolling U.S....
