FDA grants authorization to 23andMe for direct-to-consumer genetic test for cancer risk

(c) 23andMe

23andMe, Inc. has received the first-ever FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows the company to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer.

Diabetes may be a group of five different diseases

(c) CDC

A new analysis published in The Lancet Diabetes and Endocrinology indicates researchers were able to distinguish 5 new subgroups of patients with adult-onset diabetes, representing a first step toward precision medicine for the roughly 415 million patients with the chronic condition.

Ohr Pharmaceuticals' MAKO study utilizing Squalamine and Lucentis does not meet primary endpoint

(c) AAO

Ohr Pharmaceutical, Inc. has reported topline data from the MAKO study that did not meet its primary efficacy endpoint. The study evaluated efficacy and safety of topically administered squalamine in combination with monthly Lucentis® injections for the treatment of wet age-related macular degeneration. The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis.

Removable Drug Delivery Implant based on a Spider's Web to control Type 1 Diabetes

(c) Cornell Univ

For the more than 1 million Americans who live with type 1 diabetes, daily insulin injections are literally a matter of life and death. And while there is no cure, a Cornell-led research team has developed a device that could revolutionize management of the disease.

Doctors for the first time edit genome in a living human patient

(c) AP Photo/Eric Risberg

For the first time ever, doctors have edited the genome of a living human patient. A 44-year-old man received the treatment for Hunter's syndrome at a hospital in Oakland, California on November 13.

FDA approves the first digital pill that tracks compliance

Source: Proteus Digital Health

The Food and Drug Administration has approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
 

Studies show stem cell-based treatment safe in macular degeneration

Results from two early clinical trials show that it may be possible to use human embryonic stem cells as treatment for the dry form of macular degeneration, according to presentations at the American Academy of Ophthalmology Annual Meeting 2017 in New Orleans, LA. Stem cells injected into the eye appear to have replaced the missing cells damaged by the disease, with no serious side effects.