Merck & Co. Eyes Neuroscience Advancement With US FDA’s New Receptivity To Biomarkers

Company is ‘anxious to understand’ how to utilize the agency’s views on importance of biomarkers, exec notes in earnings call. Merck & Co. and Pfizer advance COVID-19 therapeutics into Phase III. Pfizer is awaiting FDA risk-benefit assessment of JAK-1 inhibitors Xeljanz and abrocitinib.

Neuroscience
Merck & Co. notes changing regulatory landscape on use of biomarkers in neuroscience drug development • Source: Alamy

Merck & Co., Inc. is looking to see how the US Food and Drug Administration’s openness to using biomarkers in Alzheimer’s disease drug development may affect its programs.

During its 29 July second quarter earnings call, an analyst asked about the company’s interest in expanding its neuroscience footprint now that there is apparently a more favorable environment at the FDA

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