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Psoriasis

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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Valeant Announces Positive Results of Second Late-Stage Study for its Psoriasis Treatment

LAVAL, Quebec, Jan. 10, 2017 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)  (“Valeant” or the “Company”) today announced positive results from a second confirmatory pivotal Phase 3, multicenter double-blind, randomized, vehicle-controlled clinical study to assess the safety and efficacy of IDP-118 (halobetasol propionate and tazarotene) lotion …

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Janssen Submits Application for Expanded Approval of Stelara in Plaque Psoriasis

HORSHAM, Pa., Dec. 16, 2016 /PRNewswire/ — Janssen Biotech, Inc. (Janssen) announced today the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe …

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Purdue and Exicure Collaborate for a New Treatment for Psoriasis and Other Diseases Utilizing SNA Technology

STAMFORD, Conn. & SKOKIE, Ill.–(BUSINESS WIRE)–Purdue Pharma L.P. and Exicure, Inc. today announced a strategic research collaboration, option and license agreement to discover and develop a treatment for psoriasis, and other diseases amenable to a gene regulation approach utilizing Exicure’s Spherical Nucleic Acid (SNA)™ technology. Purdue Pharma, upon exercise of …

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Momenta’s Humira Biosimilar Succeeds in Late-Stage Psoriasis Study

CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion …

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Janssen Submits US Marketing Application for Guselkumab for Treatment of Psoriasis

HORSHAM, Pa., Nov. 17, 2016 /PRNewswire/ — Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal …

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