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 …
Tag Archives: incyte
October, 2018
September, 2018
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12 September
Incyte and Foundation Medicine Partner to Develop Companion Diagnostic for Pemigatinib in Patients with Cholangiocarcinoma
WILMINGTON, Del. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc., today announced that the companies have entered into an agreement for the development, regulatory support and commercialization of companion diagnostics (CDx), with an initial focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with …
July, 2018
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20 July
Study Published in The Lancet Shows Benefit of Baricitinib for the Treatment of Systemic Lupus Erythematosus
INDIANAPOLIS, July 19, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that results of a global systemic lupus erythematosus (SLE) Phase 2 study for baricitinib were published by The Lancet. The study, the first completed Phase 2 study of a JAK inhibitor in SLE, showed that a statistically …
June, 2018
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4 June
FDA Approves Olumiant for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, June 1, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation(NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or …
April, 2018
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25 April
FDA Committee Recommends Approval of Baricitinib for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
INDIANAPOLIS, April 23, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis …
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6 April
Incyte’s Investigational Epacadostat in Combination with Merck’s Keytruda Fails to Meet Primary Endpoint in Phase 3 Melanoma Trial
WILMINGTON, Del. & KENILWORTH, N.J.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s KEYTRUDA® in patients with unresectable or …
January, 2018
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8 January
Incyte and Syros Enter Global Target Discovery and Validation Collaboration Focused on Myeloproliferative Neoplasms
WILMINGTON, Del. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Incyte Corporation (NASDAQ:INCY) and Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) announced today that the companies have entered into a target discovery, research collaboration and option agreement. Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative …
October, 2017
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26 October
Incyte and MacroGenics Collaborate for Anti-PD-1 Monoclonal Antibody MGA012
WILMINGTON, Del. & ROCKVILLE, Md.–(BUSINESS WIRE)–Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) announced today that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the …
June, 2017
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5 June
Incyte’s Epacadostat in Combination with Merck’s Keytruda Demonstrates Clinical Activity Across Multiple Tumors Types
WILMINGTON, Del. & KENILWORTH, N.J.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, will be highlighted …
April, 2017
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14 April
Lilly and Incyte Announce FDA Fails to Approve Baricitinib for Rheumatoid Arthritis
INDIANAPOLIS–(BUSINESS WIRE)–Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA). The …