Home / Autoimmune Disorders

Autoimmune Disorders

FDA Grants Fast Track Designation to Lilly’s Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, Dec. 13, 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 granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and …

Read More »

FDA Approves Catalyst’s Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome

CORAL GABLES, Fla., Nov. 29, 2018 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Firdapse® (amifampridine) 10 mg tablets for the treatment of …

Read More »

FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …

Read More »

Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …

Read More »

Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet

CHICAGO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR …

Read More »

FDA Approves Label Update for Genentech’s Rituxan for Treatment of Two Rare Forms of Vasculitis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the Rituxan® (rituximab) label to include information on follow up treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and …

Read More »

Bristol-Myers Squibb to Showcase Immunoscience Research and Biomarker-Guided Treatment Approaches at ACR/ARHP Annual Meeting

PRINCETON, N.J–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that 28 abstracts related to ORENCIA® (abatacept) and the Company’s immunoscience pipeline will be presented at the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, October 19-24, 2018, in Chicago. The abstracts accepted for presentation include clinical and …

Read More »

Biohaven Acquires Option to License the University of Connecticut’s Investigational Agent for Inflammatory and Autoimmune Diseases

NEW HAVEN, Conn., Oct. 9, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it signed an exclusive, worldwide option and license agreement with the University of Connecticut for the development and commercialization rights to UC1MT, a therapeutic antibody targeting extracellular metallothionein (MT). Extracellular MT has been implicated in …

Read More »

Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the FDA

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018. …

Read More »

Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the EADV Congress

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata (AA), an autoimmune disease characterized by hair loss and …

Read More »