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Although a new FDA guidance recommends difference in pain scores as the primary efficacy endpoint for evaluation of postoperative analgesic effect, data on outcomes such as reduction in hospitalization and deaths from opioid abuse would be valuable and could provide a basis for inclusion in labeling; guidance is part of broader agency effort to reduce opioid use.
Biotech stock indices have seen a recent recovery but remain well below their 2021 peaks raising questions about the likelihood of raising money for R&D. The number of companies announcing leadership changes, shifting pipeline priorities and job cuts is rising as a result.
Ahead of the usual flurry of deal-making in January, Roche gets retinal cell therapy candidate from Lineage Cell Therapeutics, Pfizer subsidiary Amplyx licenses antiviral candidate to Vera, and GSK expands neurology tie-up with Ligand.
Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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