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March 3, 2014
08:15 EDTRDHLRedHill Biopharma, IntelGenx submit response to FDA CRL for VersaFilm product
IntelGenx announced, together with RedHill Biopharma that they submitted a response to the Complete Response Letter of the U.S. Food and Drug Administration for the New Drug Application for their VersaFilm Oral Film Product for the treatment of acute migraines.The companies previously reported on February 4 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL. IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm NDA, and will provide additional updates as and when applicable.
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July 1, 2015
07:09 EDTRDHLRedHill Biopharma receives notice of allowance for two U.S. patents for RHB-104
RedHill Biopharma announced that it has received two notices of allowance from the United States Patent and Trademark Office regarding its patent application numbers 13/722,395 and 14/271,758 covering RHB-104. RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties, currently undergoing a first Phase III study for Crohn's disease and a Phase IIa study for multiple sclerosis.
June 29, 2015
07:08 EDTRDHLRedHill Biopharma initiates Phase I/II study of ABC294640
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