Ranbaxy’s First-To-File ANDAs At Risk In FDA Data Integrity Probe
Several first-to-file ANDAs are on the line for Ranbaxy as it tries to resolve data integrity issues at its Paonta Sahib facility with U.S. FDA
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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.
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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.
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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
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GSK will assume full control of mRNA shots in infectious disease, allowing CureVac to cut costs and pivot its research to oncology.
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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.
