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RedHill Biopharma Announces Planned Expansion of COVID-19 Study to U.S.
americanpharmaceuticalreview
February 26, 2021
RedHill Biopharma has announced its plans to expand the Company's global Phase 2/3 study of opaganib in patients with severe COVID-19 to the U.S., following U.S. Food and Drug Administration (FDA) review of the data from the U.S. Phase 2 study of ...
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RedHill and Cosmo Strengthen Manufacturing Agreements
contractpharma
February 20, 2021
Secures manufacturing capacity of Movantik for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.
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RedHill Biopharma Announces First Patient Dosed in U.S. Phase 2/3 COVID-19 Outpatient Study with RHB-107
prnasia
February 18, 2021
RedHill Biopharma Ltd. announced that the first patient was dosed in its U.S. Phase 2/3 study of orally-administered RHB-107 (upamostat)[1], an investigational new drug for patients with symptomatic COVID-19 who do not require hospital care.
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RedHill Biopharma Announces Positive DSMB Review for Phase 2/3 COVID-19 Study of Opaganib
americanpharmaceuticalreview
February 04, 2021
RedHill Biopharma announced the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of ...
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RedHill and Cosmo Expand Opaganib Manufacturing Deal
contractpharma
February 03, 2021
New agreement expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study.
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RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals
prnasia
January 29, 2021
RedHill Biopharma Ltd. announced a manufacturing agreement with Cosmo Pharmaceuticals NV to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640), to address prospective demand subsequent to potential global emergency use authorizations.
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RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease
americanpharmaceuticalreview
January 14, 2021
RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) ...
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RedHill gets DSMB recommendation to continue Phase II/III Covid-19 study
pharmaceutical-technology
December 23, 2020
RedHill Biopharma has received a second unanimous DSMB recommendation to continue the global Phase II/III study of opaganib (Yeliva, ABC294640) in patients hospitalised with severe Covid-19 pneumonia.
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RedHill's COVID-19 Candidate Reduces ARDS-Related Blood Clotting in Preclinical Study
americanpharmaceuticalreview
December 16, 2020
RedHill Biopharma announced promising preliminary results from a preclinical study within which opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, (administered at 250mg/kg,) demonstrating a reduction of thrombosis ...
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RedHill to Continue Phase 2/3 COVID-19 Study with Opaganib
americanpharmaceuticalreview
December 04, 2020
RedHill Biopharma announced that the global Phase 2/3 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an ...