A high dose of filgotinib, the JAK1 inhibitor under long-term development by Gilead Sciences Inc. and Galapagos NV, proved effective in a Phase IIb/III study as a treatment for patients with moderately to severely active ulcerative colitis.
FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda
Blockbusters, Checkpoint Inhibitors, Classical Hodgkin Lymphoma, Complete Response Letter, Dosing, FDA, FDA/Regulatory, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Merkel cell carcinoma, Primary Mediastinal B-Cell Lymphoma (PMBCL), Supplemental Biologics License Application (sBLA)Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
Intent Solutions, an Atlanta-based company that provides technology to secure medications and track prescription adherence, is collaborating with AT&T to integrate LTE-M cellular technology into the new release of Intent’s tad dispensing system.