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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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

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. Bossuyt PM.

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Drug Development Regulations Laboratories FDA 52

Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

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Regulations FDA Science Production 40