Otsuka Obtains U.S. FDA Fast Track Review For Dry AMD Oral Treatment
This article was originally published in PharmAsia News
Executive SummaryU.S. FDA granted a fast track review of Otsuka's dry age-related macular degeneration oral treatment ACU-4429. Developed by Tokyo-based Otsuka Pharmaceutical and Bothell, WA-based biotech Acucela, ACU-4429 is in Phase II studies in the U.S. Utilizing Accuela proprietary visual cycle modulation technology, the compound is developed to prevent or inhibit the generation of toxic byproducts that can lead to degenerative eye conditions like dry AMD. (Click here for more - Japanese language
You may also be interested in...
Nearly 500 shipments of illegal and unapproved prescription drugs and combination medical devices were seized at US borders thanks to Operation Broadsword.
Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.
Biotech licenses drug composition patents from University of Alaska Fairbanks for study in several disease states. Gilead seeks long-acting HIV therapy or prevention with broadly neutralizing antibodies discovered by Rockefeller U.