Clinical Trials (Phase IV)
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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.
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Phase 4 PALADIN Study with ILUVIEN® Published in Peer-Reviewed Journal Ophthalmology
2/23/2022
Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), announced today that the 3-year results of the PALADIN study have been published in the peer-reviewed journal Ophthalmology.
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A new study published in the journal Nature found that two patients with leukemia who were treated with CAR T-cell therapy are still in remission 10 years later.
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Clinical trial news definitely picked up this final week of January. Here’s a look.
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Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
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Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®
1/27/2022
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint.
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As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
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Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
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Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.
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The Centers for Medicare and Medicaid Services indicated it would cover the cost of these drugs and any necessary scans — but only “if they are enrolled in qualifying clinical trials.”
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Another drug Vounatsos heralded was zuranolone, which Biogen is developing with Sage Therapeutics for multiple forms of depression.
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Theravance Biopharma, Inc. Announces Enrollment of First Patient in YUPELRI® Phase 4 Study
1/10/2022
Theravance Biopharma, Inc. announced enrollment of the first patient in a Phase 4 study of YUPELRI® inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease.