Tag Archives: Graft-Versus-Host Disease

October, 2018

25 October
FDA Grants Priority Review to Incyte’s Ruxolitinib for Treatment of Patients with Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids. The FDA grants Priority Review …
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21 June
Kalytera Provides Update on its Cannabis-Based Therapy for Prevention and Treatment of GVHD

SAN FRANCISCO and TEL AVIV, Israel, June 21, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the “Company” or “Kalytera”) today provided an update on its lead clinical development program evaluating cannabidiol (“CBD”) for the prevention and treatment of acute graft versus host disease (“GVHD”). GVHD is a …
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31 January
Cases of Encephalopathy Force the FDA to Place Clinical Hold on Studies of Bellicum’s Lead Candidate BPX-501

HOUSTON, Jan. 30, 2018 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501 have been placed on a clinical hold following three …
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7 December
AbbVie’s Imbruvica Benefits Treatment-Resistant GVHD Patients in Mid-Stage Study

NORTH CHICAGO, Ill., Dec. 6, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic …
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24 June
FDA Grants Breakthrough Therapy Designation to Incyte’s Jakafi for GVHD

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD. Breakthrough Therapy Designation is designed …
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