LEBANON, N.J., Aug. 25, 2020 /PRNewswire/ -- Recordati Rare Diseases Inc., today announced the U.S. Food and Drug Administration (FDA) has approved CYSTADROPS® (cysteamine ophthalmic solution) 0.37%. CYSTADROPS is a new, viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis. CYSTADROPS demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the first and only FDA-approved cysteamine drop formulation with four times a day dosing. Cystinosis is a rare genetic condition present from birth that leads to the build-up of cystine crystals throughout the body, causing widespread tissue and organ damage and significant impact on the eyes.
BOULDER, Colo.--(BUSINESS WIRE)-- Crestone, Inc. today announced a grant award from the National Institutes of Health for the preclinical evaluation of its antibiotic candidate CRS3123 to treat infections caused by Helicobacter pylori. CRS3123 is also entering a phase 2 clinical study for treatment of Clostridioides difficile infections under a separate NIH contract with Crestone.
Enforcement Report - Week of April 25, 2018
Canada’s Patented Medicine Prices Review Board (PMPRB) is actively investigating the price of Horizon Pharma’s Procysbi (cysteamine bitartrate), a treatment for an inherited medical condition called nephropathic cystinosis.
Canadian authorities are reviewing whether Horizon Pharma (HZNP) violated pricing and advertising laws in connection with its efforts to boost sales of a newly approved rare disease drug that costs about $230,000 and replaced an older, similar medicine — which cost a fraction of the price.
Enforcement Report - Week of March 7, 2018