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Psoriasis

Largest Psoriasis Meta-Analysis to Date Yields New Genetic Clues

It’s one of the most common immune-mediated diseases in the U.S., causing red, patchy and scaly marks on the skin. Yet the 1 to 2 percent of the population who have psoriasis are still left to wonder why. A new study builds on the genetic architecture of psoriasis, the next …

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FDA Accepts for Review Pfizer’s sNDA for Xeljanz for Treatment of Patients with Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also …

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Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …

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Valeant Prices Injectable Psoriasis Drug Siliq at $3,500 Per Month

LAVAL, Quebec, April 21, 2017 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that following the evaluation and approval of its Patient Access and Pricing Committee (PAPC), the company has decided to list SILIQ™ (brodalumab) injection, at $3,500 per month, which is the lowest injectable …

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Kadmon’s Psoriasis Drug Improved Clinical Scores in Patients in Phase 2 Study

NEW YORK–(BUSINESS WIRE)–Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today announced the publication of clinical data from its completed Phase 2 open-label clinical trial of KD025, its oral Rho-associated coiled-coil kinase 2 (“ROCK2”) inhibitor, in patients with moderate to severe psoriasis. In the study, KD025 treatment improved clinical scores …

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New Data Demonstrate Sandoz Proposed Biosimilar Adalimumab has Equivalent Efficacy to Reference Medicine

Holzkirchen, 6 March 2017 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today presented data for its proposed biosimilar adalimumab (GP2017). The Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira®1. Results …

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Celgene’s Oral Otezla Demonstrates Positive Results in Study of Psoriasis Patients Naïve to Systemic and Biologic Therapy

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that results from its phase 4 UNVEIL trial evaluating OTEZLA® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate plaque psoriasis with a body surface area (BSA) of 5-10 percent, were presented at the American Academy of Dermatology’s …

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Janssen’s Guselkumab Succeeds in Two Late-Stage Studies in Patients with Moderate-to-Severe Psoriasis

ORLANDO, Fla.–(BUSINESS WIRE)–Janssen Research & Development, LLC (Janssen) announced today new findings from two pivotal Phase 3 studies reporting the efficacy and safety of guselkumab in the treatment of adults with moderate to severe plaque psoriasis.1–3 Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced significant …

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FDA Approves Valeant’s Siliq for Treatment of Psoriasis

LAVAL, Quebec , Feb. 16, 2017 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) (“Valeant” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SILIQ™ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the …

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FDA and EMA Accept Boehringer Ingelheim’s Biosimilar Candidate to Humira for Review

Ingelheim, Germany, January 18, 2017 – Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA). “We believe that if approved, BI 695501 can provide a valuable …

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