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Hey, Merck, All the Other Pharmas and Biotechs Want to Thank You

"You wouldn't know it from the lack of fanfare, but the Food and Drug Administration is getting its biggest overhaul in a decade in a dramatic coda to Merck's withdrawal of the blockbuster painkiller Vioxx three years ago." So begins this article from Forbes, which details the changes outlined for the agency in a new bill that has passed both the US House and Senate and is expected to be signed into law. "The bill represents a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with," the article says, noting that major changes include more authority for FDA in labeling claims; the ability to require drug companies to conduct clinical trials even after a drug is approved; and a rule that companies list clinical trials and results in a national, publicly accessible online database.

 

The Scan

Transcriptomic, Epigenetic Study Appears to Explain Anti-Viral Effects of TB Vaccine

Researchers report in Science Advances on an interferon signature and long-term shifts in monocyte cell DNA methylation in Bacille Calmette-Guérin-vaccinated infant samples.

DNA Storage Method Taps Into Gene Editing Technology

With a dual-plasmid system informed by gene editing, researchers re-wrote DNA sequences in E. coli to store Charles Dickens prose over hundreds of generations, as they recount in Science Advances.

Researchers Model Microbiome Dynamics in Effort to Understand Chronic Human Conditions

Investigators demonstrate in PLOS Computational Biology a computational method for following microbiome dynamics in the absence of longitudinally collected samples.

New Study Highlights Role of Genetics in ADHD

Researchers report in Nature Genetics on differences in genetic architecture between ADHD affecting children versus ADHD that persists into adulthood or is diagnosed in adults.