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TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib
[1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The positive and unanimous DSMB recommendation is a significant milestone in the progress of our development program for COVID-19 disease. Taken together with the positive results from the Phase 2 study, this unanimous DSMB recommendation to continue the global P
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TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/
RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ( Cosmo ) to further expand manufacturing capacity for opaganib (Yeliva
®, ABC294640)
[1], to address prospective demand subsequent to potential global emergency use authorizations. The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics,
said Reza Fathi, PhD., RedHill s Senior VP, R&D. We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo s quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with dem
Credit: RedHill Biopharma
New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains
TEL AVIV, Israel and RALEIGH, NC, January 28, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ( Cosmo ) to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640) , to address prospective demand subsequent to potential global emergency use authorizations. The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics. said Reza Fathi, PhD., RedHill s Senior VP, R&D. We are very pleased to expand the manufacturing capacity of opaganib with a p
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