Clinical Trials (Phase III)
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SaNOtize Obtains Health Canada Approval to Begin Enrolment for Phase III Trials for COVID-19 Anti-Viral Treatment
6/23/2021
SaNOtize Research and Development Corporation (“SaNOtize” or “the company”) announced that it has received approval from Health Canada to proceed with enrollment of volunteers in Phase III trials following earlier positive Phase II results for its Nitric Oxide Nasal Spray (NONS) for the prevention and early treatment of COVID-19 and its variants.
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BioCardia Announces Fourth Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
6/23/2021
BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306).
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BioVie Receives FDA Guidance for Phase 3 Clinical Trial of BIV201 in HRS-AKICompany Planning a Potentially Pivotal Study in This Life-Threatening Complication of Ascites
6/23/2021
BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for the treatment of liver disease and neurological and neurodegenerative disorders and certain cancers, today announced the results of a Type B meeting request submitted to the Food & Drug Administration (“FDA”) regarding its planned Phase 3 study of BIV201 (continuous infusion terlipressin) in hepatorenal syndrome–acute kidney injury (“HRS-AKI”).
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Anti-TIGIT Domvanalimab-Based Combinations Showed Encouraging Clinical Activity in People with Metastatic, PDL1-High Non-Small Cell Lung Cancer at First Interim Analysis of Arcus Biosciences’ Randomized Phase 2 ARC-7 Study
6/23/2021
Arcus Biosciences, Inc. (NYSE:RCUS), today announced that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as an initial treatment (first-line) to people with metastatic, PD-L1≥50% non-small cell lung cancer (NSCLC).
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First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
6/23/2021
Pfizer Inc. announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial.
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Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy (Omidubicel)
6/23/2021
Gamida Cell Announces Publication in Blood , the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy (Omidubicel) for Patients with Blood Cancer who Require an Allogeneic Stem Cell Transplant
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Spruce Biosciences shared results from two Phase II studies assessing tildacerfont, a non-steroidal, oral antagonist for the treatment of adult patients with classic CAH.
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Roche presented results from several Phase II and III trials at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting held virtually June 19-22.
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Cuba’s Abdala vaccine is 92% effective against the novel coronavirus, according to a recent analysis of late-stage trials.
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Please check out the biopharma industry's COVID-19 stories that are trending for June 22, 2021.
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Sintilimab in Combination with Chemotherapy Meets Overall Survival Primary Endpoint in the Global Phase 3 ORIENT-15 Study for the First-Line Treatment of Esophageal Squamous Cell Carcinoma
6/22/2021
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced that the Phase 3 ORIENT-15 study met the predefined overall survival primary endpoint
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Preliminary Results From RELIANT Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Pancreatic Cancer
6/22/2021
Corcept Therapeutics today announced preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer.
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uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update
6/22/2021
uniQure N.V. (NASDAQ: QURE), today announced positive 52-week clinical data on all patients from its pivotal, Phase III HOPE-B gene therapy trial of etranacogene dezaparvovec, an investigational adeno-associated virus five (AAV5)-based gene therapy for the treatment of patients with severe and moderately severe hemophilia B.
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Photocure: Asieris Announces First Patient Administration in Europe within the Phase III Clinical Trial for APL-1702 (Cevira)
6/22/2021
Photocure ASA announces that its partner Asieris Pharmaceuticals has administered the first European patient in its phase III clinical trial for APL-1702.
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Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Patients With Persistent, Recurrent or Metastatic Cervical Cancer
6/22/2021
Merck, known as MSD outside the United States and Canada, announced that the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy with or without bevacizumab, met its primary endpoints of overall survival and progression-free survival for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer.
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Asieris Announces First Patient Treated in Europe in APRICITY, the Multinational Phase III Clinical Trial of APL-1702, Cevira®
6/22/2021
Asieris Pharmaceuticals announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial of its photodynamic drug-device combination product APL-1702, Cevira® which is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions.
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Clinical Catch-Up: June 14-18
6/21/2021
It was another busy week of clinical trial announcements. Here’s a look. -
CymaBay Therapeutics Presents Positive PBC Data at the International Liver Congress™ 2021
6/21/2021
CymaBay Therapeutics, Inc. today announced positive data from its previously completed Phase 2 study and the ENHANCE Phase 3 study of seladelpar in patients with primary biliary cholangitis.
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Cassava Sciences Selects Clinical Research Organization for Phase 3 Clinical Program in Alzheimer’s DiseaseSelection of Premier Research as CRO Marks Significant Milestone Toward Initiation of Phase 3 Program of Simufilam in Alzheimer’s Disease
6/21/2021
Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the selection of Premier Research International as its clinical research organization (CRO) to help conduct the Phase 3 clinical program of simufilam for Alzheimer’s disease.
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Sierra Oncology Announces Completion of Enrollment for MOMENTUM Phase 3 Trial
6/21/2021
Sierra Oncology, Inc., a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, announced the completion of enrollment for its pivotal Phase 3 MOMENTUM clinical trial evaluating the novel JAK1, JAK2 and ACVR1 / ALK2 inhibitor momelotinib in myelofibrosis patients who are symptomatic and anemic.