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News Breaks
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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December 18, 2014
06:18 EDTRDHLRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 17, 2014
06:14 EDTRDHLRedHill Biopharma enrolls first patients in Phase III study of RHB-102
Red Hill announced that the randomized, double-blind, placebo-controlled Phase III study with RHB-102 for acute gastroenteritis and gastritis is underway in the U.S., with a planned enrollment of 320 patients. Top-line results from the Phase III GUARD study are expected during 2H15. RedHill recently submitted a European Marketing Authorization Application seeking approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. Results are intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. In parallel, RedHill is pursuing marketing approval for RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.

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