New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Agency IQ

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Drug Target Review

NOVEMBER 27, 2024

Clinical validity: defining biomarker performance. Scandinavian Journal of Clinical and Laboratory Investigation. 2010 Jan 1;70(sup242):46-52. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Journal of immunological methods.

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New Drug Approvals

APRIL 21, 2025

6] Clinical trials Phase I data indicated acoramidis achieved near-complete (>90%) TTR stabilization across the entire dosing interval at steady state. [12] Acoramidis AG-10 1446711-81-4 AG10 Acorami 292.30 for 10 minutes. The mixture was then heated to 555 C. with stirring. 9 (1): 115129. doi : 10.1002/cpdd.700. PMC 7003869.

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