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.

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.
 

Beware: Using colored contact lenses on Halloween may lead to blindness!

Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween. Also remember what eating lots of sweet candy can do to your or your children's body.

It always pays to be aware and careful. Happy Halloween!

Leber Hereditary Optic Neuropathy - The Gene Therapy race to treatment

GenSight Biologics, which is in advanced stages of clinical development of gene therapy for Leber Hereditary Optic Neuropathy, has a new Chief Medical Officer. Barrett Katz, M.D., M.B.A., who until recently was the Professor of Ophthalmology, Neurology and Neurosurgery at the Montefiore Medical Center and the Albert Einstein College of Medicine in New York. Dr. Katz has worked in both academic medicine and the industry as a neuro-ophthalmologist, working as CEO of ophthalmic biotech Danube Pharmaceuticals, as well as CMO of Fovea Pharmaceuticals and VP of medical affairs and strategy at Eyetech.

Biosimilars and clinical care - information for healthcare providers - Part I

A significant number of people, both in clinics and in pharmaceutical industry, mention the fact that they keep hearing of the word 'biosimilars' in academic meetings and in discussions, but they have no idea what they are, and what they do. Considering that biosimilars are likely to affect the way we practice medicine in the days ahead, it is important that we are aware of what biosimilars mean, and what they do. Also, it is important from the pharmaceutical industry perspective that everyone is knowledgeable of the process for an approval. Lastly, there is a minuscule, but very relevant question, about legal implications, which may or may not break your/your company's back in getting the drug to the market! The last two topics will be covered in subsequent posts.