Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of applications it's unprepared to handle.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of applications it's unprepared to handle.
"I'm concerned we will not have the staff because we're always waiting to catch up," Woodcock told the members of...
Optimizing Drug Pipelines With Biophysical Methods”, your view into how using biophysical techniques can enhance and streamline processes throughout the drug discovery and validation cycle.
CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
GSK will assume full control of mRNA shots in infectious disease, allowing CureVac to cut costs and pivot its research to oncology.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
