Latest News - Phase 3/4 Trials

Tuesday, September 26, 2017 | Personnel/Company News, Phase 3/4 Trials, PracticalDermatology.com, Novan

Novan Has Guidance Meeting with FDA on SB204

Novan, Inc. is eyeing an additional pivotal trial for its investigational treatment for acne vulgaris, SB204. The company concluded a guidance meeting with the FDA regarding SB204 in which t…

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Wednesday, September 20, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Research and Publications

Two-Year Data: TREMFYA™ (guselkumab) Achieves Consistent Rates of Skin Clearance in Moderate to Severe Plaque Psoriasis

New longer-term data from the open-label extension of the VOYAGE 1 trial demonstrate consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate…

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Wednesday, September 13, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Novartis

Five-Year Data Show Sustained Efficacy, Safety for Cosentyx

Novartis’ IL-17 blocker Cosentyx® (secukinumab) maintains PASI 90 and PASI 100 response rates at five years in patients with moderate to severe plaque psoriasis, according to new Phase …

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Monday, September 11, 2017 | Phase 3/4 Trials, PracticalDermatology.com, PracticalDermatology.com, Research and Publications

Lilly to Present New Data for Olumiant® and Taltz® at EADV

Eli Lilly and Company will present Phase 2 safety and efficacy data evaluating Olumiant® (baricitinib) for the treatment of moderate-to-severe atopic dermatitis (Lilly and Incyte Corporation …

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Thursday, September 07, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Research and Publications

Dermira Presents New Data on Late-Stage Programs at European Dermatology Congress

Dermira, Inc. will present data from its glycopyrronium tosylate (formerly DRM04) and Cimzia (certolizumab pegol) Phase 3 clinical programs in poster sessions at the 26th European Academy of Dermatolo…

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Thursday, August 31, 2017 | FDA Approval/Clearance, Healthcare Trends, Phase 3/4 Trials, PracticalDermatology.com, PracticalDermatology.com, Product Launches and Updates, Research and Publications

GBI Research: Global Dermatology Pipeline Will See Shift Toward Increased Use of Biologics

The global dermatology pipeline, which currently comprises 850 products with a disclosed stage of development, is primarily made up of drugs at an early stage of development, with the late stages of t…

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Thursday, August 03, 2017 | Phase 3/4 Trials, PracticalDermatology.com

Aclaris Submits Marketing Authorization Application in Europe for A-101 40% for Seborrheic Keratosis

Aclaris Therapeutics, Inc. has submitted a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for its product candidate A-101 40% Topical Solution for the trea…

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Monday, July 17, 2017 | Phase 3/4 Trials

Paratek: Phase 3 Study of Oral-Only Dosing of Omadacycline Met FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections

Paratek Pharmaceuticals, Inc. shared positive top-line results from a pivotal Phase 3 study comparing its once-daily, oral investigational antibiotic, omadacycline, to twice-daily oral linezolid in th…

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Wednesday, July 05, 2017 | Phase 3/4 Trials, PracticalDermatology.com

Array BioPharma Submits NDAs for Binimetinib and Encorafenib in Advanced Melanoma

Array BioPharma submitted two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once da…

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Thursday, June 15, 2017 | Phase 3/4 Trials, PracticalDermatology.com

PsA Patients Failing Anti-TNF Drugs May Do Well on Taltz

New data show that Taltz (ixekizumab) improved the signs and symptoms of active psoriatic arthritis (PsA) in patients who had inadequate response to one or two TNF inhibitors or were intolerant o…

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Wednesday, June 07, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Sun Pharmaceutical Industries Ltd

Tildrakizumab Performs Well in Two Phase 3 Psoriasis Studies

Two Phase 3 trials show that tildrakizumab is efficacious and well-tolerated in patients with moderate-to-severe chronic plaque psoriasis. Specifically more than 60 percent of all patients who rece…

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Monday, April 24, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Research and Publications

Paratek: Phase 3 Data Show Omadacycline Effective Against Common Skin Pathogens, Including MRSA

Analysis of microbiology data from a Phase 3 study of omadacycline in acute skin infections shows that once-daily treatment with IV-to-oral omadacycline is effective in treating the most frequently is…

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Thursday, April 06, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Galderma

Phase 4 Studies of Restylane® Refyne and Restylane® Defyne Show Lasting Natural Benefit

Two Phase 4 clinical studies of Restylane® Refyne and Restylane® Defyne show that the natural-looking results last. Specifically, the Natural Expression study found that…

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Monday, March 27, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Research and Publications, Allergan

Allergan and Paratek Pharmaceuticals' Acne Drug Performs Well in Phase 3 Trials

Allergan and Paratek Pharmaceuticals, Inc.’s investigational acne drug performed well in two Phase 3 studies, the companies report. Sarecycline, a once-daily, oral, narrow spectrum tetracycli…

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Monday, March 06, 2017 | Phase 3/4 Trials, PracticalDermatology.com, Novartis, Psoriasis

Sandoz Proposed Biosimilar Shows Equivalent Efficacy to Humira

Sandoz’s proposed biosimilar adalimumab (GP2017) shows equivalent efficacy to reference medicine, according to data presented at the American Academy of Dermatology (AAD) in Orlando, Florida. …

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