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Skipping a Step


The recent problems involving Avastin — in which FDA decided to yank its approval for the drug to be used as a treatment for metastatic breast cancer — shows the importance of carrying out follow-up studies for cancer treatments, says In the Pipeline's Derek Lowe. Now, it seems some companies are skipping that step, which, Lowe adds, "isn't good." Conditional approval is granted by FDA as a way to get a needed drug to patients while waiting for more data. But some companies are slowing down the follow-ups either because they're having trouble rounding up enough patients for the trials or because they're worried about the results. "Opinions are all over the place on how lenient the FDA's approval process really is," Lowe says. "You have people who say that the agency is dragging its feet on life-saving treatments, and people (looking at the same data set) who say that they're letting too much stuff through on the flimsiest grounds." But no matter what side of the argument you're on, he adds, everyone can agree that "we're going to require evidence at some point."

The Scan

Single-Cell Sequencing Points to Embryo Mosaicism

Mosaicism may affect preimplantation genetic tests for aneuploidy, a single-cell sequencing-based analysis of almost three dozen embryos in PLOS Genetics finds.

Rett Syndrome Mouse Model Study Points to RNA Editing Possibilities

Investigators targeted MECP2 in mutant mouse models of Rett syndrome, showing in PNAS that they could restore its expression and dial down symptoms.

Investigators Find Shared, Distinct Genetic Contributors to Childhood Hodgkin Lymphoma

An association study in JAMA Network Open uncovers risk variants within and beyond the human leukocyte antigen locus.

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.