Skip to main content
Premium Trial:

Request an Annual Quote

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

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.