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February 4, 2014
08:13 EDTIGXT, RDHLRedHill Biopharma, IntelGenx receive complete response letter from FDA
RedHill Biopharma (RDHL) together with IntelGenx (IGXT) announced that they received a Complete Response Letter, or CRL from the FDA regarding the New Drug Application for RHB-103 for the treatment of acute migraines. RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies. While continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks. RedHill and IntelGenx have been in active discussions with potential partners for the commercialization of RHB-103 and expect to advance these discussions rapidly following FDA's CRL which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding RHB-103's safety.
News For RDHL;IGXT From The Last 14 Days
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August 27, 2015
07:19 EDTRDHLRedHill receives notice of allowance for Israeli patent for Crohn's treatment
RedHill Biopharma announced that it has received a Notice of Allowance from the Israeli Patent Office for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Once granted, the patent is expected to be valid through at least 2029. The new patent allowance in Israel further extends the geographic reach of RedHill's intellectual property for RHB-104 and is an addition to already granted U.S. patents and pending filings in other countries.
August 24, 2015
09:05 EDTRDHLRedHill reports peer-reviewed publication showing potential of ABC294640
RedHill Biopharma announced the publication of an article evaluating the therapeutic potential of ABC294640, the company's orally-administered first-in-class Sphingosine kinase 2, or SK2, selective inhibitor, in the treatment of prostate cancer. The article, authored by scientists from Apogee Biotechnology and from the Kimmel Cancer Center at Thomas Jefferson University, will be published in Molecular Cancer Research and is available online on the journal's website. RedHill acquired the rights to Yeliva in March from U.S.-based Apogee. RedHill has also filed a trademark application with the U.S. Patent and Trademark Office for the new brand name Yeliva for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will beYeliva. The article1, entitled "Downregulation of Critical Oncogenes by the Selective SK2 Inhibitor ABC294640 Hinders Prostate Cancer Progression", describes a pre-clinical study conducted with Yeliva in early stage and advanced prostate cancer models. The findings from the study suggest that oral administration of ABC294640 disrupts multiple oncogenic signaling pathways that are deregulated in prostate cancer, corresponding with significant inhibition of tumor growth, proliferation and cell cycle progression. In particular, the compound inhibited in vitro several very resistant types of prostate cancer. The authors of the article conclude that these pre-clinical findings support the hypotheses that SK2 activity is required for prostate cancer function and that ABC294640 could represent a new pharmacological agent for the treatment of early stage and aggressive prostate cancer. The study was supported by a grant from the Pennsylvania Department of Health, a Prostate Cancer Foundation Young Investigator award, and a Prostate Cancer Foundation Mazzone Challenge award.

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