The Washington Post – In a historic move, the Food and Drug Administration approved a pioneering gene therapy for a rare form of childhood blindness, the first such treatment cleared in the United States for an inherited disease.
Regulatory Affairs Professionals Society – The FDA published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations and to determine if an in vitro diagnostic device must undergo its own FDA review.
Axios – Medicine is poised to be one place where AI makes a mark. In a study published this week, researchers report that a machine algorithm was as good — or better — than pathologists at detecting the spread of a type of breast cancer.
National Institutes of Health – A new clinical trials consortium funded by the National Institutes of Health is expected to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias.
FierceBiotech – A research team has created a form of CRISPR/Cas9 that can activate targeted genes without making breaks in the DNA. Eliminating the need to physically cut the DNA can cut down on the harmful side effects that might come with CRISPR.
Medscape – In a wide-ranging hearing, Francis Collins of the NIH and Scott Gottlieb of the FDA commented on the progress they have made in implementing the 21st Century Cures Act in the year since the legislation was passed.
Gizmodo – A powerful and controversial new genetic engineering technology offers the potential to drastically reshape our world by overriding natural selection. And the US military’s research arm is among one of the technology’s biggest research funders.