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Monday, January 18, 2021

BioBiz: Seattle Cancer Care Alliance receives the recently authorized COVID-19 vaccine; FSD Pharma begins dosing in COVID-19 trials

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The Seattle Cancer Care Alliance (SCCA), the only National Comprehensive Cancer Network (NCCN)- member cancer center in Washington state, was selected by the Washington State Department of Health to be one of the first 17 sites to receive the recently authorized COVID-19 vaccine. SCCA will receive a portion of the 32,000 doses allotted to Washington State hospitals and will vaccinate its staff, helping to protect the vulnerable patient population that SCCA serves and preserving access to cancer care in the Puget Sound region.

Gilead Sciences, Inc. and Galapagos NV have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA.

Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in RA in the United States and that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without conducting substantial additional clinical studies.

DiaMedica Therapeutics Inc. announced that the last participant has been enrolled and is on treatment in the diabetic kidney disease Cohort of the Company’s Phase 2 REDUX chronic kidney disease (CKD) study. The Company also announced that enrollment has reached 50% in the IgA Nephropathy and African Americans cohorts.

Additionally, the study is designed to identify African American participants with the APOL1 gene mutation as an exploratory biomarker as these individuals have an even higher risk of developing CKD. Cohort 2 of the study is focused on participants with IgA Nephropathy (IgAN) and Cohort 3 includes participants with diabetic kidney disease.

FSD Pharma Inc. began dosing patients in its Phase 2a clinical trial of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized patients with COVID-19. The FSD201 COVID-19 Trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice daily, together with the standard of care compared to SOC alone in hospitalized patients with documented COVID-19 disease. Eligible patients will present symptoms consistent with influenza/coronavirus signs (fever, dry cough, malaise, difficulty breathing) and newly documented positive COVID-19 disease.

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