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Psoriasis

Dermavant Enters $330 Million Deal for Rights to GSK’s Investigational Psoriasis Drug

GSK today announced that Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programmes for a total consideration of £250 million, including an initial payment …

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FDA Fails to Approve Valeant’s Plaque Psoriasis Treatment

LAVAL, Quebec, June 18, 2018 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for DUOBRII™1 (halobetasol propionate and tazarotene) …

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Gilead and Galapagos Announce Positive Results with Filgotinib in Psoriatic Arthritis and Progression into Phase 3 Ulcerative Colitis Study

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in …

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AbbVie Submits Risankizumab BLA to the FDA for Treatment of Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe …

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Pfizer’s Xeljanz and Xeljanz XR Receive FDA Approval for the Treatment of Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response …

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FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …

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Lilly’s Taltz Receives FDA Approval for the Treatment of Active Psoriatic Arthritis

INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for …

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FDA Accepts Ortho Dermatologics’ NDA for IDP-118 for the Treatment of Plaque Psoriasis

LAVAL, Quebec, Nov. 2, 2017 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for …

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AbbVie’s Risankizumab Beats Humira and Stelara in Late-Stage Psoriasis Studies

NORTH CHICAGO, Ill., Oct. 26, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque …

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Janssen’s Simponi Aria Receives FDA Approval for Psoriatic Arthritis and Ankylosing Spondylitis

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s …

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