A US Court Asks Stem Cell Clinics to Stop Manufacturing and Marketing Products without Regulatory approval

(c) The Atlantic

U.S. District Judge Ursula Ungaro of the Southern District of Florida has issued an order that stops US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.

Regeneron's PANORAMA study for Eylea in Diabetic Retinopathy shows Promise

(c) PMLive

Regeneron Pharmaceuticals, Inc. announced positive topline data from its Phase III PANORAMA clinical trial of Eylea (aflibercept) injection in moderately severe to severe non-proliferative diabetic retinopathy. Diabetic retinopathy, which affects about eight million people, is the result of microvascular damage to the blood vessels in the retina related to lack of blood sugar control in diabetic patients.

FDA to soon decide approval for Spark Therapeutics' gene therapy for Leber Congenital Amaurosis

In the next few days, FDA panel will consider whether to advice approval for gene therapy for Leber's Congenital Amaurosis (LCA), which has been extensively tested in clinical trials by Spark Therapeutics.

FDA approves medical device that helps patients monitor their vision

Vital Art and Science Inc. has a U.S. Food and Drug Administration (FDA) clearance to market myVisionTrack, a prescription-only medical device that enables patients with retinal diseases to monitor their vision function between regular visits to their eye-care professional to help ensure they obtain timely care and treatments.

Amarantus Applies for Orphan Drug Designation for MANF in treatment of Retinitis Pigmentosa

Amarantus Bioscience Holdings, Inc., a biotechnology company focused on the development of diagnostics and therapeutics for Alzheimer's disease, Parkinson's disease and ophthalmological disorders, announced that it has applied to the Food & Drug Administration in the US for Orphan Drug Designation for MANF (mesencephalic-astrocyte-derived neurotrophic factor) in retinitis pigmentosa (RP).