Latest News - Phase 3/4 Trials

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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Thursday, March 02, 2017 | Phase 3/4 Trials, PracticalDermatology.com, American Academy of Dermatology, Sun Pharmaceutical Industries Ltd

Sun Pharma to Present Data from Tildrakizumab Clinical Development Program at 2017 AAD Meeting

Sun Pharmaceutical Industries Ltd will present several new analyses from Phase-1 and the pivotal Phase-3 clinical trials (reSURFACE 1 and 2) of tildrakizumab, an investigational IL-23p19 inhibitor bei…

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Friday, January 27, 2017 | Personnel/Company News, Phase 3/4 Trials, PracticalDermatology.com, Research and Publications, Novan

Topline Results from Novan's SB204 Phase 3 Pivotal Trials: Inconsistent Across Trials

Novan, Inc. (NASDAQ:NOVN) today announced  top-line results from the Company’s two, replicate Phase 3 pivotal clinical trials for SB204 in the treatment of acne vulgaris. In the intent-to-t…

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Monday, November 28, 2016 | Personnel/Company News, Phase 3/4 Trials, PracticalDermatology.com, Research and Publications

Patient Enrollment Complete in Phase 3 Acne Trials for Minocycline Foam FMX101

Patient enrollment is now complete for two Phase 3 clinical trials evaluating the efficacy and safety of FMX101, a topical 4 percent minocycline foam for the treatment of moderate-to-severe acne, acco…

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Wednesday, October 19, 2016 | Personnel/Company News, Phase 3/4 Trials

Study Calls Attention to Negative Impact, Need for Treatment of SK

Patients with asymptomatic seborrheic keratosis (SK) are bothered by highly visible skin lesions and are very interested in treatment to improve their appearance, even if a cost were associated with t…

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Monday, October 10, 2016 | Phase 3/4 Trials, PracticalDermatology.com

Phase 3 Study: Yervoy Improves Overall Survival in Fully Resected Stage III Melanoma Patients

Yervoy 10 mg/kg demonstrated superiority versus placebo on all survival endpoints in the Phase 3 trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence…

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Monday, October 10, 2016 | Phase 3/4 Trials, PracticalDermatology.com

Opdivo Stabilized Patient-reported Outcomes in Previously Treated Recurrent or Metastatic SCC of Head and Neck

Bristol-Myers Squibb Company reported new patient-reported quality-of-life data from an exploratory endpoint in the pivotal Phase 3 CheckMate -141 trial evaluating Opdivo in patients with recurrent or…

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