Clinical Trials (Phase IV)
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Xenon Pharmaceuticals Outlines Key Milestone Opportunities for 2023
1/9/2023
XEN1101 Phase 3 Epilepsy Program Ongoing in Focal Onset Seizures and Recently Initiated in Primary Generalized Tonic Clonic Seizures.
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Massachusetts General Hospital Reports Results of Interim Analysis from REFINE-ALS Biomarker Trial by Mitsubishi Tanabe Pharma USA, Utilizing Oxford Biodynamics’ EpiSwitch® Platform for Prognostic Stratification of Fast Progression ALS
12/16/2022
Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch® 3D genomics platform, announces the initial results from an interim analysis conducted for the REFINE-ALS prospective trial.
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Mitsubishi Tanabe Pharma America Presents Interim Data from REFINE-ALS Biomarker Study at 21st Annual NEALS Meeting
11/2/2022
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an interim analysis of the Phase 4 REFINE-ALS study, designed to identify predictive and pharmacodynamic biomarkers to measure the effect of RADICAVA® (edaravone) in people with amyotrophic lateral sclerosis (ALS).
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Merck, Bristol Myers Squibb, Biogen and others presented their latest data from MS programs at the 38th ECTRIMS conference.
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Paladin Phase 4 Study Confirms ILUVIEN® Patients' Reduced Need for Multiple Treatments
10/6/2022
Alimera Sciences, Inc. announced that post-hoc analyses from the PALADIN Phase 4 Safety Study demonstrate that median treatment frequency in diabetic macular edema patients treated with the ILUVIEN® 0.19 mg was lower than from patients on other regimens.
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Horizon Therapeutics plc Completes Enrollment for Phase 4 Trial of TEPEZZA® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)
9/29/2022
Horizon Therapeutics plc Completes Enrollment for Phase 4 Trial of TEPEZZA ® (teprotumumab-trbw) in Adults with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED).
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Paladin Phase 4 Study Confirms Safety of Durable ILUVIEN® Treatment and Reduces Burden of Care For DME Patients
7/26/2022
Alimera Sciences, Inc. announced that the PALADIN Phase 4 Study confirms the safety of ILUVIEN® 0.19 mg sustained release intravitreal implant and provides a durable treatment option that reduces the frequency of recurrence for patients with diabetic macular edema.
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BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients' lives are being affected.
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Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm after only 29 people signed up for an expected enrollment of 6,000 patients.
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Real World Study Demonstrates Consistent Survival for Gilead’s Yescarta Across Race/Ethnicity
6/6/2022
The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity. -
Intercept Announces New Clinical Trial and Real-World Outcomes Data for Ocaliva in PBC
6/3/2022
COBALT study in advanced PBC, previously terminated early due to feasibility challenges, did not demonstrate a statistically significant difference in clinical endpoints between Ocaliva ® and placebo HEROES-US real-world analysis demonstrated statistically significant improvement in event-free survival in patients receiving Ocaliva for PBC,
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Phase 4 PALADIN Study Confirms Positive Predictive Value of Corticosteroid Course Prior to ILUVIEN® Use for IOP Outcomes
5/12/2022
Alimera Sciences, Inc. announced that the phase 4 PALADIN study confirmed the benefit of using a prior course of corticosteroid as indicated in the ILUVIEN® U.S. label to mitigate the risk of uncontrolled intraocular pressure elevation.
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Biofrontera Launches New Patient-Focused Websites for Ameluz® and Xepi®
4/21/2022
Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of new and updated websites for its two products, Ameluz® and Xepi®.
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Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
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Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase 4 ENVISION Trial to FDA
3/30/2022
Biogen Inc. (Nasdaq: BIIB) has submitted the final study protocol for the confirmatory Phase 4 ENVISION trial to the U.S. Food and Drug Administration (FDA) for review and approval.
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Clarus Announces Initiation of Phase 4 Clinical Trial of JATENZO® (testosterone undecanoate) for the Treatment of Hypogonadal Men with Chronic Kidney Disease
3/16/2022
Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced the initiation of screening for the first patient in an investigator-initiated Phase 4 clinical trial designed to evaluate the efficacy and safety of JATENZO.
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Baudax Bio Initiates Phase IV Clinical Trial Evaluating ANJESO® in Pediatric Patients Following Surgery
3/8/2022
Baudax Bio, Inc. a pharmaceutical company focused on commercializing and developing innovative products for acute care settings, announced initiation of a clinical study evaluating the safety and pharmacokinetics of ANJESO injection in pediatric patients following surgery.
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Fulcrum Therapeutics will launch a Phase III study of losmapimod in people with facioscapulohumeral muscular dystrophy later this year. Tonix wins Orphan Drug designation for Prader-Willi asset.
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The FDA places holds, companies receive clearance for new studies and Pharma giants release new data in last week's clinical trial news.
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Interim Phase 4 Data Support TAKHZYRO® (lanadelumab) as an Effective Treatment to Reduce Attacks in Hereditary Angioedema Patients
2/28/2022
Interim Phase 4 Data Support TAKHZYRO ® (lanadelumab) as an Effective Treatment to Reduce Attacks in Hereditary Angioedema Patients.