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FDA Approves Pfizer’s Biosimilar Abrilada (adalimumab-afzb) for Multiple Inflammatory Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.2 For full details …

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Evelo Biosciences Reports Further Positive EDP1815 Interim Clinical Data in Patients with Psoriasis at High Dose in Phase 1b Trial

CAMBRIDGE, Mass., Nov. 05, 2019 (GLOBE NEWSWIRE) — Evelo Biosciences (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced positive interim clinical data in an ongoing Phase 1b trial in individuals with mild to moderate psoriasis treated with a high dose …

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Janssen Presents New 4-Year Tremfya Data Demonstrating Maintained Rates of Skin Clearance in Moderate to Severe Plaque Psoriasis

LAS VEGAS, Oct. 17, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the Phase 3 VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving TREMFYA® (guselkumab) in the combined group of patients initially randomized to TREMFYA or …

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Phase 3 Psoriasis Study of Bimekizumab Meets All Endpoints, Achieving Significantly Greater Efficacy vs Placebo and Ustekinumab

BRUSSELS, Oct. 17, 2019 /PRNewswire/ — Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive results from BE VIVID, the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate-to-severe …

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New Head-to-Head Data Show Taltz Superiority vs. Tremfya in Patients with Moderate to Severe Plaque Psoriasis

TORONTO, Oct. 10, 2019 (GLOBE NEWSWIRE) — Eli Lilly and Company presented detailed data at the 5th Annual Maui Derm NP+PA Fall meeting from the Phase 4 IXORA-R study, the first head-to-head (H2H) study between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 …

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Janssen Seeks FDA Approval of Stelara for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

SPRING HOUSE, Pa., Oct. 7, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis …

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Janssen Submits sBLA to the FDA Seeking Approval of Tremfya for Treatment of Adult Patients with Active Psoriatic Arthritis

HORSHAM, Pa., Sept. 16, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis …

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Amgen to Acquire Celgene’s Psoriasis Drug Otezla for $13.4 Billion in Cash

THOUSAND OAKS, Calif., Aug. 26, 2019 /PRNewswire/ — Amgen (NASDAQ: AMGN) announced today that it has entered into an agreement with Celgene Corporation (NASDAQ: CELG) in connection with its previously announced merger with Bristol-Myers Squibb Company (NYSE: BMY) to acquire worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets …

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Lilly’s Taltz Demonstrates Superiority Over Tremfya in Head-to-Head Trial in Patients with Moderate to Severe Plaque Psoriasis

INDIANAPOLIS, Aug. 13, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today Taltz® (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus TREMFYA®(guselkumab) in people living with moderate to severe plaque psoriasis (PsO). The …

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Leo Pharma Acquires Expanded Global Rights to Develop and Market Brodalumab for Moderate-to-Severe Psoriasis

BALLERUP, Denmark–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum® in the European Union) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licencing agreement with Bausch Health Ireland Limited. The …

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