Tag Archives: JAK inhibitors

April, 2018

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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25 January
FDA Approves First-Ever JAK2 Test for Use in Diagnosis of Additional Myeloproliferative Neoplasms

Hilden, Germany, and Germantown, Maryland, January 23, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs), which are …
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10 July
FDA Lifts Clinical Hold on Concert Pharma’s Mid-Stage Trial of CTP-543 in Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it has lifted the clinical hold on Concert’s CTP-543 Phase 2a clinical trial for alopecia areata. The Company will amend the protocol for the Phase 2a trial to evaluate two …
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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 …
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9 November
New Pathway Towards Treatments for Inflammatory Diseases

A molecule thought to play a key role in some inflammatory diseases can be switched off by two widely used medicines, new research has shown. Scientists at the Universities of Bradford and Glasgow (UK) have identified a new biochemical pathway that can be controlled using metformin – a medicine used …
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15 April
Galapagos’ Oral Rheumatoid Arthritis Candidate Meets Primary Endpoint in Phase II Study

Belgium-based Galapagos NV said that its oral JAK1 inhibitor, in development for treatment of patients with rheumatoid arthritis (RA), met key endpoints in its mid-stage study. The company’s selective JAK1 inhibitor filgotinib showed improvements in signs and symptoms of active RA and met key efficacy endpoints after 12 weeks of …
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