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March 7, 2014
07:15 EDTRDHLRedHill Biopharma secures direct rights to original RHB-102 patents
RedHill Biopharma reported that it has secured direct rights from Temple University to the original RHB-102 patents, a once-daily oral formulation of the anti-emetic drug ondansetron. As previously reported by the company, SCOLR Pharma, which originally licensed certain patents to RedHill for RHB-102, announced that it had ceased business operations. Since SCOLR had itself licensed those patents from Temple University, the original owner of the patents, RedHill has now licensed those same patents directly from Temple University. The new licensing agreement with Temple University is under similar financial terms as the previous agreement with SCOLR, which has been terminated by RedHill. The company also reports that, following the completion of several previously-announces clinical studies, a pre-NDA meeting was held with the FDA regarding RHB-102's development for chemotherapy and radiotherapy-induced nausea and vomiting. Following the pre-NDA meeting, and in light of the FDA's feedback, RedHill provided the FDA with additional information and is currently awaiting the FDA's response. Given the ongoing discussions with the FDA, the company believes that the NDA for RHB-102 will not be submitted in the first quarter of 2014 as planned. RedHill will provide an update on the expected timeline for NDA submission of RHB-102 as soon as sufficient regulatory clarity is obtained, based on the outcome of the discussions with the FDA. In parallel to pursuing the CINV and RINV indications, RedHill is also pursuing a new indication for RHB-102. The company expects that, if approved by the FDA, the new indication would significantly expand the potential market for RHB-102. To support the submission of an NDA targeting this additional new indication, RedHill is planning a Phase III clinical study later this year. In parallel to advancing the regulatory pathways in the U.S. for multiple indications, RedHill also plans to submit, later this year, a Marketing Authorization Application for RHB-102 in Europe for CINV and RINV. RedHill plans to conduct a comparative bioavailability study comparing RHB-102 to a European reference product ahead of the MAA submission.
News For RDHL From The Last 14 Days
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March 3, 2015
07:08 EDTRDHLAmerican Society for Clinical Pharmacology and Therapeutics holds meeting
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March 2, 2015
07:20 EDTRDHLRedHill Biopharma reports two poster presentations for Bekinda
RedHill Biopharma reported the presentation of two posters at the American Society for Clinical Pharmacology and Therapeutics, or ASCPT, 2015 Annual Meeting, to be held between March 3-7, 2015 in New Orleans. The posters describe two previously reported comparative bioavailability studies for Bekinda, a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron. RedHill is developing Bekinda for the indications of gastroenteritis and gastritis as well as chemotherapy and radiotherapy-induced nausea and vomiting. The posters will be presented at the ASCPT meeting by the Canadian Contract Research Organization, or CRO, who conducted the bioavailability studies for RedHill. The first study compared the plasma levels of the active ingredient ondansetron after a dose of Bekinda versus FDA-approved regimens of either Zofran 8 mg given twice daily or as a single 24 mg dose. The randomized, crossover study in 18 healthy volunteers also assessed the accumulation of ondansetron in plasma after administering five consecutive daily doses of Bekinda under fasting conditions, as well as the safety and tolerability of Bekinda. The results of the study demonstrated that the plasma levels of ondansetron after Bekinda were similar or higher than the plasma levels after Zofran 8 mg b.i.d, thus indicating that the efficacy of Bekinda is at least as good as Zofran 8 mg b.i.d. The study further demonstrated that the safety and tolerability of Bekinda were similar to the safety profile of the FDA-approved regimens of ondansetron. The second comparative bioavailability study evaluated the influence of food on the pharmacokinetics of Bekinda in healthy volunteers. The randomized, crossover study demonstrated that, consistent with the commercially available Zofran 8 mg immediate-release formulation, food delayed the absorption of Bekinda and increased the maximal concentrations and extent of absorption of the ondansetron. Despite these increases, which are not expected to have clinical significance, the number and severity of adverse events were lower under fed conditions.
February 26, 2015
07:54 EDTRDHLRedHill Biopharma reports Q4 EPS 6c, may not compare to two estimates (60c)

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