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Aducanumab Approval

The US Food and Drug Administration has approved the Alzheimer's disease treatment aducanumab, NPR reports. It adds that this is the first approval of an Alzheimer's disease treatment in 18 years.

But whether aducanumab works is unclear, NPR adds. Biogen, the drug's maker, terminated trials of the drug in patients after an early analysis suggested it was not working as hoped. But as Time magazine reported in 2019, the company decided to seek FDA approval for the drug following a re-analysis that suggested one trial showed a slowing of cognitive decline among some Alzheimer's disease patients. Regulators at FDA appeared to support the approval, as Stat News reported last November, but an outside advisory panel was less certain that the drug was effective and additionally seemed perturbed that FDA asked it to focus on the positive study, as NPR reported then.

NPR now reports that FDA approved aducanumab, which is to be marketed by Biogen as Aduhelm, under its accelerated approval pathway and with the stipulation that Biogen conduct another clinical trial. The Washington Post reported last week that some critics were calling for another trial prior to FDA approval.

As Science adds, the FDA usually accepts the recommendations of its outside panel of advisors, and some critics sees this approval as a weakening of standards at the agency. Others have lauded the approval and say it will spark further investment in Alzheimer's disease therapies.

The Scan

Team Tracks Down Potential Blood Plasma Markers Linked to Heart Failure in Atrial Fibrillation Patients

Researchers in BMC Genomics found 10 differentially expressed proteins or metabolites that marked atrial fibrillation with heart failure cases.

Study Points to Synonymous Mutation Effects on E. Coli Enzyme Activity

Researchers in Nature Chemistry saw signs of enzyme activity shifts in the presence of synonymous mutations in a multiscale modeling analysis of three Escherichia coli genes.

Team Outlines Paternal Sample-Free Single-Gene Approach for Non-Invasive Prenatal Screening

With data for nearly 9,200 pregnant individuals, researchers in Genetics in Medicine demonstrate the feasibility of their carrier screening and reflex single-gene non-invasive prenatal screening approach.

Germline-Targeting HIV Vaccine Shows Promise in Phase I Trial

A National Institutes of Health-led team reports in Science that a broadly neutralizing antibody HIV vaccine induced bnAb precursors in 97 percent of those given the vaccine.