Ranbaxy May Be Hit With Significant Disgorgement Penalty For GMP Violations
MUMBAI - Ranbaxy's long-running encounter with U.S. FDA over American regulatory allegations of significant deficiencies at two Ranbaxy manufacturing sites - Paonta Sahib and Dewas - may be headed for a settlement in coming months, with the Indian generics flag-bearer paying out several million dollars in penalties
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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.
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