Clinical Trials (Phase IV)
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Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
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With over 20% of people born between 1997 and 2003 identifying as a sexual and gender minority, moderated panels at SCOPE 2024 discuss the need to engage this community in clinical trials.
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While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
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Theravance Biopharma Announces Results from the Phase 4 YUPELRI® PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
1/5/2024
Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced results from the Phase 4 PIFR-2 study of YUPELRI® (revefenacin) inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD.
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Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults
12/6/2023
Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in the head and neck region in adults (N=31).
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A failed rare disease clinical trial brings social media expertise to the pharma industry and patient recruitment: A discussion with Bryan Manning, founder of Clinical Enrollment and Two Blind Brothers
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AMGEN PRESENTS NEW RESEARCH IN EARLY PSORIATIC ARTHRITIS AT ACR 2023
11/7/2023
Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla® (apremilast) in patients with early oligoarticular psoriatic arthritis.
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Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
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MannKind Announces Completion of Enrollment in U.S. Phase 4 Inhale-3 Clinical Trial in Patients Living With Type 1 Diabetes
11/6/2023
MannKind Corporation announced that it has fully enrolled patients in INHALE-3, a Phase 4 clinical trial evaluating inhaled insulin versus usual care in adults living with type 1 diabetes.
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High multiplexed patient-centric assays could reduce patient burden
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Dermavant Presents Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference
10/20/2023
Dermavant Presents Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference.
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Teva Phase IV UNITE Study Shows AJOVY® (fremanezumab) Reduced Migraine Attacks and Depression Symptoms in Migraine Sufferers with Major Depressive Disorder
10/17/2023
Teva Pharmaceutical Industries Ltd. announce that data from the UNITE study presented at the World Congress of Neurology in Montreal, Canada, show that AJOVY® reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder.
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CEQUA® (cyclosporine ophthalmic solution) 0.09% Phase 4 Data Showed Sustained Improvement in Dry Eye Disease Signs and Symptoms in Patients Switched From Restasis® (cyclosporine ophthalmic emulsion) 0.05%
10/12/2023
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED).
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First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity
10/11/2023
Genentech, a member of the Roche Group, announced results from the Phase IV CHIMES trial evaluating Ocrevus® in Black and Hispanic / Latinx people with relapsing multiple sclerosis.
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CymaBay Initiates AFFIRM, a Phase 3b/4 Study Evaluating the Effect of Seladelpar on Clinical Outcomes in Patients with Cirrhosis due to Primary Biliary Cholangitis
9/21/2023
CymaBay Therapeutics, Inc. today announced the initiation of AFFIRM, a randomized, placebo-controlled confirmatory study to evaluate the effect of seladelpar on clinical outcomes in patients with compensated cirrhosis due to primary biliary cholangitis (PBC).
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Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar
8/1/2023
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira ® (adalimumab).
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SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study
7/26/2023
AbbVie (NYSE: ABBV) today announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI® (risankizumab) compared to Otezla® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy.1
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The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
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Grifols Achieves Positive Topline Results From Phase 4 Study of XEMBIFY® (immune globulin subcutaneous human-klhw) Evaluating Biweekly Dosing Option for Patients
7/20/2023
Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that its recently concluded phase 4 trial (NCT04566692) evaluating a biweekly dosing of XEMBIFY® has met its primary endpoint.
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The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.