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Suggestions for Drug Approvals

A regulatory system for approving new drugs is certainly necessary, says In the Pipeline's Derek Lowe, but is it the right system? Lowe references an article at BioCentury that suggests an adaptive system instead of one that makes binary decisions. In other words, Lowe says, the idea is to set things up so that data can be generated quickly, that decisions can be made on that data, and then modified when additional findings come out. Biomarkers should also be an important part of early-phase clinical work, he says, as should the wider use of conditional approvals and adaptive clinical trials. "Another way to speed things up with adaptive designs would be to run several new therapies in a given space simultaneously, re-assigning patients as the more effective candidates show themselves," Lowe adds. "If the trials are going on continuously, the barriers to getting in on them would be lower than they are under the current system, where everyone has to start their own work from the ground up." It would be a big adjustment to make, but the ideas, he says, have merit, and should be given more scrutiny.

The Scan

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.

Study Uncovers Genetic Mutation in Childhood Glaucoma

A study in the Journal of Clinical Investigation ties a heterozygous missense variant in thrombospondin 1 to childhood glaucoma.

Gene Co-Expression Database for Humans, Model Organisms Gets Update

GeneFriends has been updated to include gene and transcript co-expression networks based on RNA-seq data from 46,475 human and 34,322 mouse samples, a new paper in Nucleic Acids Research says.

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.