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Psoriasis

Celgene’s Otezla Meets Primary Endpoint in Phase 3 Study in Moderate to Severe Scalp Psoriasis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced results from the phase 3 STYLE study, which showed that OTEZLA® (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response [defined as ScPGA score of clear (0) or almost clear …

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Bausch Health Announces Tentative FDA Approval of Bryhali Lotion for Adult Patients with Plaque Psoriasis

LAVAL, Quebec, Oct. 8, 2018 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALI™ (halobetasol propionate) Lotion, 0.01%, for …

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Patient-Reported Outcomes Data from Three Phase 3 Studies of Risankizumab Show Significant Improvements in Health-Related Quality of Life for Psoriasis Patients

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in …

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Janssen’s Tremfya Improves Long-Term Patient-Reported Outcomes in Patients with Moderate to Severe Plaque Psoriasis

PARIS–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data that show considerable improvements in long-term patient-reported outcomes (PRO) in patients switched to TREMFYA® (guselkumab) after an initial inadequate response to adalimumab.1 In addition, PRO measurement tools such as the Psoriasis Symptom and Sign Diary (PSSD) may provide a …

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Biosimilar Cyltezo Demonstrates Clinical Equivalence to Humira in Patients with Moderate-to-Severe Plaque Psoriasis

RIDGEFIELD, Conn., Sept. 12, 2018 /PRNewswire/ — Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo® is equivalent to Humira®*, with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association …

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Celgene’s Otezla Showed Meaningful Improvements in Clinical and Quality-of-Life Measures of Psoriasis Beyond Those Captured by Assessing Skin Alone

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced the results of two post hoc sub-analyses of clinical trials for OTEZLA® (apremilast) at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Findings suggest OTEZLA offered meaningful improvements in outcomes important to patients with moderate to severe plaque psoriasis, which may …

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Bristol-Myers Squibb’s TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) …

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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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