Clinical Trials - Phase III
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Sound Pharma completes enrollment in pivotal Phase 3 clinical trial of SPI-1005 for the treatment of Meniere's disease involving hearing loss, tinnitus, and dizziness.
5/3/2023
Sound Pharmaceuticals is pleased to announce that it has completed enrollment in its first Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere's Disease (STOPMD-3).
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ELAHERE® Demonstrates Overall Survival Benefit in the Phase 3 MIRASOL Trial in Patients with FRα-Positive Platinum-Resistant Ovarian Cancer
5/3/2023
ImmunoGen Inc. (Nasdaq: IMGN) today announced positive top-line data from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy.
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Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease
5/3/2023
Eli Lilly and Company announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease.
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Alzheimer's Association Statement on Donanemab Phase 3 Topline Data Release
5/3/2023
On behalf of the millions of Americans impacted by the devastation of Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes the robustly positive topline data reported by Eli Lilly on the TRAILBLAZER-ALZ2 Phase 3 clinical trial of donanemab for the treatment of early symptomatic Alzheimer's disease.
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Amolyt Pharma Announces Phase 3 Clinical Trial of Eneboparatide for the Treatment of Hypoparathyroidism following Positive End of Phase 2 Meeting with FDA
5/2/2023
Amolyt Pharma today announced that it will initiate its Phase 3 clinical trial of eneboparatide, a long-acting parathyroid hormone 1 (PTH1) receptor agonist, in patients with hypoparathyroidism following the receipt of End-of-Phase 2 guidance from the U.S. Food and Drug Administration (FDA).
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NLS Pharmaceutics Receives Green Light from the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy
5/2/2023
NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) ("NLS" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience® (Mazindol ER).
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Verona Pharma to Present Expanded Analyses of Positive Phase 3 ENHANCE Studies in COPD in Multiple Presentations at ATS 2023
5/2/2023
Verona Pharma plc announces 12 abstracts, including a mini symposium, and a clinical trials symposium, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease have been accepted by the American Thoracic Society International Conference 2023.
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Revive Therapeutics Announces Data Safety Monitoring Board Meeting Date on Phase 3 Clinical Study of Bucillamine in the Treatment of COVID-19
5/2/2023
Revive Therapeutics Ltd. announced that the independent Data and Safety Monitoring Board meeting of the Bucillamine Phase 3 clinical trial for COVID-19 is expected to convene on May 10th, 2023 and will assess the efficacy of Bucillamine in the Study’s Post-Dose selection data under the current Study’s protocol primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization.
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Arcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
5/2/2023
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) today announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD in children ages 2 to 5.
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The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances. -
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
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Horizon Therapeutics plc Announces Initiation of Phase 3 Clinical Trial in Japan Evaluating TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)
5/1/2023
Horizon Therapeutics plc Announces Initiation of Phase 3 Clinical Trial in Japan Evaluating TEPEZZA ® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED).
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Travere Therapeutics Announces Topline Results from Two-Year Primary Efficacy Endpoint in Pivotal Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis
5/1/2023
Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced topline primary efficacy results from the pivotal Phase 3 DUPLEX Study of sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), in focal segmental glomerulosclerosis (FSGS).
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Zambon Completes Enrollment in Phase 3 Clinical Development Program Evaluating Liposomal Cyclosporine A for Inhalation (L-CsA-i) in Patients with Bronchiolitis Obliterans Syndrome (BOS)
5/1/2023
Zambon announced today that the Company has completed enrollment in its two pivotal Phase 3 studies.
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In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese. -
The French pharma drops another BTK inhibitor program from Principia and an anti-TNFa from Ablynx. -
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status. -
Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder
4/26/2023
Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT 1A agonist activity, for the treatment of generalized anxiety disorder (GAD).
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Galapagos initiates Phase 3 program with filgotinib in patients with active axial spondyloarthritis
4/26/2023
Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was randomized inOLINGUITO, the pivotal Phase 3 program of filgotinib inAxSpA.Topline results are expected in H2 2025.
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SAB Biotherapeutics Announces Positive Results from Phase 3 Trial of SAB-185 in Patients with COVID-19 at High-Risk for Severe Complications
4/26/2023
SAB Biotherapeutics announced positive top-line results from the Phase 3 National Institutes of Health’s ACTIV-2 clinical trial that assessed SAB-185 in non-hospitalized people with COVID-19 who were at high risk for severe outcomes.