Skip to main content
Premium Trial:

Request an Annual Quote

FDA Seeks Review of Approval

Janet Woodcock, the acting commissioner of the US Food and Drug Administration, is seeking an independent investigation into the agency's approval of a controversial Alzheimer's disease drug, the Financial Times reports.

The agency approved aducanumab, Biogen's Aduhelm, last month under its accelerated approval pathway despite an advisory panel determination that there was not enough data showing that the drug worked. The approval sparked resignations among advisory panel members, with Harvard Medical School's Aaron Kesselheim calling the approval a "debacle" in his resignation letter, as the Wall Street Journal reported. Stat News additionally reported there appeared to have been "off-the-books" meetings between Biogen and FDA officials.

Citing this, Woodcock called on the inspector general of the Department for Health and Human Services to review interactions between FDA staff and Biogen, FT says. "We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency's review staff were inconsistent with FDA's policies and procedures," she says in a tweet.

Biogen told Stat News it "respect[s] and followed the FDA's guidance, regulations, and processes" during the review of Aduhelm and further tells CNN that it will "cooperate with any inquiry in connection with a possible review of the regulatory process."

The Scan

Study Links Evolution of Longevity, Social Organization in Mammals

With the help of comparative phylogenetics and transcriptomics, researchers in Nature Communications see ties between lifespan and social organization in mammals.

Tumor Microenvironment Immune Score Provides Immunotherapy Response, Prognostic Insights

Using multiple in situ analyses and RNA sequence data, researchers in eBioMedicine have developed a score associated with immunotherapy response or survival.

CRISPR-Based Method for Finding Cancer-Associated Exosomal MicroRNAs in Blood

A team from China presents in ACS Sensors a liposome-mediated membrane fusion strategy for detecting miRNAs carried in exosomes in the blood with a CRISPR-mediated reporter system.

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.