Specialty Pharma Journal Specialty, Precision & Technology
LAS VEGAS, Oct. 19, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the VOYAGE 1 clinical trial demonstrating that stably maintained rates of skin clearance with TREMFYA® treatment achieved from week 52 (1 year) were maintained through week 156 (3 years) among …
Tag Archives: plaque psoriasis
October, 2018
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8 October
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 …
September, 2018
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13 September
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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12 September
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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12 September
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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12 September
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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12 September
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) …
June, 2018
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18 June
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) …
April, 2018
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25 April
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 …
November, 2017
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3 November
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 …