TEL AVIV, Israel and RALEIGH – RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the third quarter ended September 30, 2021. Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net...
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Guelph, Canada – A new editorial paper was published in Oncotarget entitled, “Reductive carboxylation of glutamine as a potential target in acute myeloid leukemia.” In this new editorial, researchers Alessia Roma, Lawrence D. Goodridge and Paul A. Spagnuolo from the University of Guelph discuss acute myeloid leukemia (AML) — an...
CLEVELAND, Ohio — Reese Pharmaceutical is expanding its over-the-counter (OTC) diagnostic portfolio with the launch of ColoTest®, an at-home Fecal Immunochemical Test (FIT) that identifies the presence of hidden blood in the stool in support of the early detection of colon cancer or gastrointestinal disorders such as colitis, diverticulitis, and polyps....
Evkeeza is a first-in-class medicine approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultra-rare inherited form of high cholesterol TARRYTOWN, N.Y. and NOVATO, C.A. – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Ultragenyx Pharmaceutical Inc. today announced a license and collaboration agreement for Ultragenyx...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor treatment indicated for...
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc., (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target...
Tarrytown, NY – Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient...
INDIANAPOLIS — A study of more than 21,000 average risk patients at 186 sites across the U.S., led by Regenstrief Institute and Indiana University School of Medicine research scientist Thomas Imperiale, M.D., has found that the next generation multi-target stool DNA colorectal cancer screening test detects 94 percent of colorectal...
ROCKVILLE, Md., – Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO’s proprietary NAV® AAV8 vector Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202...
ROCKVILLE, Md. –– REGENXBIO Inc. (Nasdaq: RGNX) today announced the publication of results from the Phase I/IIa trial evaluating the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). Two-year data were published in The Lancet in a paper titled...