Clinical Trials (Phase IV)
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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.
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.
Theravance Biopharma Announces Results from the Phase 4 YUPELRI® PIFR-2 Study in Patients with Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
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.
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
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).
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
Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla® (apremilast) in patients with early oligoarticular psoriatic arthritis.
Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
MannKind Announces Completion of Enrollment in U.S. Phase 4 Inhale-3 Clinical Trial in Patients Living With Type 1 Diabetes
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.
High multiplexed patient-centric assays could reduce patient burden
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
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.
Teva Phase IV UNITE Study Shows AJOVY® (fremanezumab) Reduced Migraine Attacks and Depression Symptoms in Migraine Sufferers with Major Depressive Disorder
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.
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%
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).
First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity
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.
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
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).
Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira ® (adalimumab).
SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study
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
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
Grifols Achieves Positive Topline Results From Phase 4 Study of XEMBIFY® (immune globulin subcutaneous human-klhw) Evaluating Biweekly Dosing Option for Patients
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.
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.
Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients
Akebia Therapeutics ® , Inc. today announced topline results from IMPACT, a Phase 4 collaborative study investigating the impact of Auryxia®.