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Review of Approval Process

The US Food and Drug Administration's controversial approval of Biogen's Alzheimer's disease drug is to be reviewed, Stat News reports.

Acting FDA Commissioner Janet Woodcock called on the Department for Health and Human Services' Office of the Inspector General last month to investigate interactions between FDA staff and Biogen, and the office now says it will be reviewing FDA's accelerated approval pathway.

The approval of aducanumab, Biogen's Aduhelm, was controversial. As Time magazine reported in 2019 Biogen sought approval for the drug after a re-analysis of data from one of its clinical trials suggested it might slow cognitive decline among some patients. But in late 2020, an FDA advisory panel determined there was not enough data indicating the drug worked, and its subsequent approval led to resignations among panel members. One member noted the approval was based on the drug's effect on amyloid in the brain, which the panel was unable to discuss. Stat News further reported previously that the agency worked unusually close with the company on approval and there may have been "off-the-books" meetings between the two.

The OIG says its investigation will include "reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes." The Washington Post notes that the OIG will not examine whether aducanumab is effective.

The Scan

Mosquitos Genetically Modified to Prevent Malaria Spread

A gene drive approach could be used to render mosquitos unable to spread malaria, researchers report in Science Advances.

Gut Microbiomes Allow Bears to Grow to Similar Sizes Despite Differing Diets

Researchers in Scientific Reports find that the makeup of brown bears' gut microbiomes allows them to reach similar sizes even when feasting on different foods.

Finding Safe Harbor in the Human Genome

In Genome Biology, researchers present a new approach to identify genomic safe harbors where transgenes can be expressed without affecting host cell function.

New Data Point to Nuanced Relationship Between Major Depression, Bipolar Disorder

Lund University researchers in JAMA Psychiatry uncover overlapping genetic liabilities for major depression and bipolar disorder.