FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues
The issue at a third-party manufacturer has been resolved, with an FDA re-inspection now planned.
22 August 2024
The issue at a third-party manufacturer has been resolved, with an FDA re-inspection now planned.
Valued at approximately $30m, the deal contributes to Emergent’s financial recovery plan amid its dramatic post-Covid decline.
The company halted the Phase II trial of its mTOR inhibitor after an independent analysis found that it would not meet the efficacy threshold.
GLP1R agonists are currently used for the treatment of type 2 diabetes (T2D) and obesity to stimulate insulin secretion and inhibit glucagon release.
The sBLA submission is supported by results from the Phase III CheckMate 9DW trial.
The funds will support Pathalys’ lead candidate upacicalcet through two clinical trials and potentially accelerate its approval.
Dupert is approved for NSCLC treatment in adults with the KRAS G12C mutation.
University of Nottingham scientists are scaling up development of a Zika virus DNA vaccine.
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