Clinical Trials (Phase III)
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Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna's stock following the data reveal.
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In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
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The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen's effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
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Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing severe exacerbations in COPD.
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Travere Therapeutics Announces Late-Breaker Presentations of the Interim Analysis from the Phase 3 PROTECT Study of FILSPARI™ (Sparsentan) in IgA Nephropathy at the ISN World Congress of Nephrology and NKF Spring Clinical Meetings 2023
3/23/2023
Travere Therapeutics, Inc. announced that the interim analysis of efficacy and safety data from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ in IgA nephropathy will be presented in late-breaking trial sessions at both the ISN World Congress of Nephrology in Bangkok, Thailand, March 30-April 2, and NKF Spring Clinical Meetings in Austin, TX, April 11-15, 2023.
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Mitsubishi Tanabe Pharma America Announces Enrollment Completion for Global, Phase 3b Study of RADICAVA ORS® (edaravone) in ALS
3/23/2023
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS® (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks.
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Risankizumab (SKYRIZI®) Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis
3/23/2023
AbbVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI®,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis.
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Journal of Clinical Psychiatry Publishes Data from Alkermes' ENLIGHTEN-Early Study of LYBALVI® (olanzapine and samidorphan) in Young Adults Early in Their Illness
3/23/2023
Alkermes plc (Nasdaq: ALKS) today announced the publication of results from its phase 3 ENLIGHTEN-Early study of LYBALVI ® (olanzapine and samidorphan) in the peer-reviewed publication, the Journal of Clinical Psychiatry.
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Yescarta is the first treatment in nearly 30 years to improve overall survival in relapsed/refractory large B-cell lymphoma R/R LBCL, according to Gilead's Kite Pharma.
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Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder
3/22/2023
Vistagen today announced positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in adults with social anxiety disorder (SAD).
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Visus Therapeutics Completes Enrollment in BRIO-I, a Phase 3 Clinical Trial of BRIMOCHOL™ PF for the Treatment of Presbyopia
3/22/2023
Visus Therapeutics Completes Enrollment in BRIO-I, a Phase 3 Clinical Trial of BRIMOCHOL ™ PF for the Treatment of Presbyopia.
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Josep Bassaganya-Riera Launches NImmune Biopharma with Phase 3-Ready Clinical Candidate Omilancor for the Treatment of Ulcerative Colitis and Crohn’s Disease
3/22/2023
NImmune Biopharma today announced its launch following the acquisition of omilancor, NIM-1324, and the entire LANCL portfolio of immunoregulatory therapeutic assets from Landos Biopharma, Inc.
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Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology
3/22/2023
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology.
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Following recent meetings with the FDA and European Medicines Agency, Mereo Biopharma is designing a Phase III study of alvelestat to treat alpha-1-antitrypsin deficiency-associated lung disease.
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Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
3/21/2023
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab.
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Kite’s Yescarta® CAR T-cell Therapy Demonstrates a Statistically Significant Improvement in Overall Survival for Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma
3/21/2023
Kite, a Gilead Company (Nasdaq: GILD), today announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study.
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Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint: Swedish Orphan Biovitrum AB
3/21/2023
Selecta Biosciences, Inc. and Sobi®, announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout.
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Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint
3/21/2023
Selecta Biosciences, Inc. and Sobi®, announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout.
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Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
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Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.