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NeuroRx and Georgian Ministry of Health Agree to Initiate Expanded Access Program of ZYESAMI (aviptadil acetate) for COVID-19 Respiratory Failure in Georgia - Vimarsana News

NeuroRx and Georgian Ministry of Health Agree to Initiate Expanded Access Program of ZYESAMI (aviptadil acetate) for COVID-19 Respiratory Failure in Georgia

Share this article Share this article RADNOR, Pa. and TBLISI, Georgia, April 28, 2021 /PRNewswire/ -- NeuroRx today announces that it has met with Dr. Ekaterine Tikaradze, Minister of Health of Georgia, and other senior leadership, to immediately initiate an Expanded Access Program (EAP) of its phase 3 drug, ZYESAMI (aviptadil acetate) for critically-ill citizens of Georgia with COVID-19 Respiratory Failure.  The EAP will be conducted in collaboration with Denk Pharma Georgia, Georgia's primary pharmaceutical distributor, and under the auspices of the Potomac Institute of Policy Studies and...

Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA - Vimarsana News

Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA

Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA USA - English Share this article Share this article CARMIEL, Israel and BOSTON, April 28, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an internat...

Cardiff Oncology Presents Findings from its Expanded Access Program Highlighting the Clinical Benefit of Onvansertib in Heavily Pretreated Patients with Metastatic KRAS-Mutated mCRC - Vimarsana News

Cardiff Oncology Presents Findings from its Expanded Access Program Highlighting the Clinical Benefit of Onvansertib in Heavily Pretreated Patients with Metastatic KRAS-Mutated mCRC

Share this article SAN DIEGO, April 10, 2021 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, today announced observations from its Expanded Access Program (EAP) of onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC), featured in a virtual oral poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2021. ...

RedHill Biopharma's Phase 2/3 COVID-19 Study of Opaganib Passes Fourth DSMB Review with Unanimous Recommendation to Continue - Vimarsana News

RedHill Biopharma's Phase 2/3 COVID-19 Study of Opaganib Passes Fourth DSMB Review with Unanimous Recommendation to Continue

(1) Independent Data Safety Monitoring Board unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 pneumonia based on review of unblinded safety data from the first 255 treated patients The 464-patient global Phase 2/3 COVID-19 study is over 75% enrolled, with completion of enrollment expected in the coming weeks Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Bi...

Researchers develop assay for qualitative assessment of SARS-CoV-2 neutralizing antibodies - Vimarsana News

Researchers develop assay for qualitative assessment of SARS-CoV-2 neutralizing antibodies

To address the need for a high-quality neutralization assay against SARS-CoV-2, researchers from the NIAID modified and optimized a previously established fluorescence reduction neutralization assay (FRNA) to provide a quantitative assessment of a large number of infected cells through the use of a high-content imaging system.