THOUSAND OAKS, Calif. — Amgen announced today that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough...
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According to a report published in Blood, addition of the novel E-selectin inhibitor uproleselan to both an intensive chemotherapy-based salvage regimen and a standard intensive frontline regimen was safe, well tolerated, and active in patients with acute myeloid leukemia (AML). Expression of E-selectin in the bone marrow microenvironment contributes to drug...
MAPLE GROVE, Minn. — Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of KYMBEE™ (deflazacort) Tablets, indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Manufactured by Upsher-Smith in Minnesota, KYMBEE™ is the only deflazacort backed by Upsher-Smith’s Promise of Support® Program. Available in 6 mg, 18 mg, 30 mg, and...
Göttingen, Germany – In individuals with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), uric acid (UA) metabolism might be involved in activation of the complement system and thus serve as a contributory factor in the disease course, according to findings from a retrospective study published in the International Journal of Molecular...
PRINCETON, N.J. — UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with MEDAC GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers. UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, is a...
Minnesota nice is being proven all over again. A young man from Africa says he is proof of that as doctors in St. Paul rebuild not only his face but his entire future. Even for skilled specialists, the surgical case on the table before them is a challenge. “It’s kind...
Orphan Therapeutics, LLC and Ikaria Holdings, Inc announced that the US Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for Lucassin (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type-1. The filing was completed on May...
Basel, Switzerland – Sandoz, a global leader in biosimilar and generic medicines, today announced that the US Supreme Court has denied its petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi® (etanercept-szzs) for reference medicine Enbrel®* (etanercept). The Federal Circuit previously ruled against Sandoz in...
Los Angeles, Calif. – Acute lymphoblastic leukemia (ALL), the most common childhood cancer, especially affects children of Hispanic/Latino origin in the United States. They are 30-40% more likely to get ALL than non-Hispanic white children, but the exact genetic basis and cause of that increased risk are unknown. Now, a...
Researchers at the Keck School of Medicine of the University of Southern California (USC) have identified a key mechanism that causes chromosomes within blood cells to break—an occurrence that marks the first step in the development of human lymphoma. The study provides researchers with the clearest insight yet into why...