Page 28 - Expanded Access Program News Today

Hyundai Bioscience Develops Injection Drug for Potential Treatment of Severe Cases of COVID-19 Published : Wednesday, December 23, 2020, 10:09 am ACROFAN=PRNewswire | mediainquiries@prnewswire.com | SNS - Expected to maintain IC100 during treatment while minimizing side effects - Expanded Access Program prior to NDA is sought to help urgent patients in blind spots SEOUL, South Korea, Dec. 23, 2020 /PRNewswire/ -- Hyundai Bioscience (KOSDAQ symbol: 048410) announced on the 23 rd, Decem...

Chiesi Global Rare Diseases Announces First Patient Treated in Expanded Access Program for Pegunigalsidase Alfa for Proposed Treatment of Fabry Disease - Program grants access to investigational therapy for Fabry disease patients in the United States who cannot be adequately treated with currently available FDA-approved drugs - News provided by Share this article Share this article BOSTON, Dec. 23, 2020 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,...

22 dicembre 2020 Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021 Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification...

RedHills Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue Top-line data from the global Phase 2/3 COVID-19 study expected Q1/2021 Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib Opaganib potentially minimizes likeli...

 E-Mail ROCHESTER, Minn. -- Patients with COVID-19 who received care at Mayo Clinic, whether in the hospital or at home, had outcomes that compared favorably to those reported nationally and internationally. These results demonstrate the value of an integrated, team-based approach to patient care and monitoring, according to a retrospective study of all patients with COVID-19 treated at Mayo Clinic March 1-July 31. Included in the research during the study period were 7,891 patients who tested...

Credit: RedHill Biopharma -- Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021 -- Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib -- Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a huma...

Credit: RedHill Biopharma Acute respiratory distress syndrome (ARDS)-induced thrombosis (blood clotting) may occur in up to one-third of COVID-19 patients requiring ICU admission and is a contributing cause of mortality Opaganib demonstrated reduced thrombosis in a preclinical model of ARDS Opaganib has also been shown to inhibit SARS-CoV-2 viral replication as well as pro-inflammatory markers in relevant preclinical models Top-line data from the U.S. Phase 2 study of orally administered opagan...

Share: NEW YORK, Dec. 14, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today the initiation of a NurOwn® (MSC-NTF cells)  Expanded Access Program (EAP) for  patients with amyotrophic lateral sclerosis (ALS) who completed the Companys recently concluded pivotal Phase 3 clinical trial and meet specific eligibility requirements. The protocol for...

[3]. RedHills key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva -in -class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohns disease; (iv) RHB-102 ( Bekinda ®)...