Clinical Trials (Phase IV)
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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.
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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 Positive Topline Data from TEPEZZA® (teprotumumab-trbw) Phase 4 Clinical Trial in Patients with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED)
4/10/2023
Horizon Therapeutics plc Announces Positive Topline Data from TEPEZZA ® (teprotumumab-trbw) Phase 4 Clinical Trial in Patients with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED).
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Takeda Announces Results From Phase 4 Vedolizumab Study in Patients With Chronic Pouchitis Published in New England Journal of Medicine
3/30/2023
Takeda (TSE:4502/NYSE:TAK) today confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase 4 EARNEST study of vedolizumab for the treatment of chronic pouchitis.
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Corcept Therapeutics Initiates CATALYST Clinical Trial
3/28/2023
Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that it has initiated CATALYST, a 1,000-patient, Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes.
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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.