Clinical Trials - Phase III
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1-Year Outcomes of Phase 3 Study for SB15, Proposed biosimilar to Eylea (aflibercept), Presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
4/24/2023
Samsung Bioepis Co., Ltd. today announced that 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea1(aflibercept), were presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana.
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Apellis Presents Phase 3 Functional Analyses of SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy
4/23/2023
Apellis Pharmaceuticals, Inc. announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE™ for the treatment of geographic atrophy secondary to age-related macular degeneration.
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Pharma Two B to Present Additional Positive Results from P2B001 Phase 3 Trial at 2023 American Academy of Neurology Annual Meeting
4/23/2023
Pharma Two B, a private, venture-backed, late-stage pharmaceutical company, announced that additional results from the Phase 3 pivotal clinical trial evaluating P2B001, will be presented at the 2023 American Academy of Neurology Annual Meeting, April 22-27 in Boston, MA.
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AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label. -
CymaBay Therapeutics Announces Publication of Results From the ENHANCE, Phase 3 Study of Seladelpar in Patients with Primary Biliary Cholangitis (PBC)
4/21/2023
CymaBay Therapeutics, Inc. today announced that results from the ENHANCE phase 3 global study evaluating seladelpar for primary biliary cholangitis (PBC) have been published in Hepatology.
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AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting
4/21/2023
AbbVie announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications.
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The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval. -
Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19
4/20/2023
Cantex Pharmaceuticals, Inc. and Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of a randomized double-blind, placebo-controlled, multicenter, phase 2/3 clinical study to evaluate the safety and efficacy of azeliragon in decreasing the incidence of acute kidney injury and other life-threatening complications in patients hospitalized for COVID-19.
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Visus Therapeutics Announces Positive Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF™ for the Treatment of Presbyopia
4/20/2023
Visus Therapeutics Announces Positive Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF ™ for the Treatment of Presbyopia.
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Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy
4/20/2023
Therapeutic Solutions International (TSOI) announced today filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome (ARDS).
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BeiGene Announces Positive Phase 3 Tislelizumab Trial in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
4/20/2023
BeiGene today announced the global RATIONALE 305 trial met its primary endpoint of overall survival, with tislelizumab in combination with chemotherapy demonstrating superior overall survival (OS) compared with chemotherapy in patients with advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status.
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Junshi Biosciences Announces Toripalimab plus Chemotherapy Significantly Improved Event-free Survival (EFS) versus Chemotherapy as Perioperative Treatment for Resectable Stage III Non-small Cell Lung Cancer (NSCLC) in Phase 3 Neotorch Study
4/20/2023
Shanghai Junshi Biosciences Co., Ltd. announced that positive interim event-free survival results from the Neotorch study were presented at the ASCO April Plenary Series.
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The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens. -
The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting. -
Vistagen Presents New Fasedienol (PH94B) Research at 2023 Anxiety and Depression Association of America Conference
4/19/2023
Vistagen today announced new data, presented at the 2023 Anxiety and Depression Association of America (ADAA) Conference in Washington, D.C.
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ANNOVIS BIO ANNOUNCES UPDATE ON RECRUITMENT INTO ITS PHASE 2/3 ALZHEIMER'S STUDY AND UPCOMING R&D WEBCAST
4/19/2023
Annovis Bio, Inc. today announced that patient recruitment for the Company's Phase 2/3 study of buntanetap for the treatment of moderate Alzheimer's disease (AD) remains consistent with its planned development program.
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Cali Biosciences Initiates Phase III Studies of CPL-01 (Long-Acting Ropivacaine) to Decrease Post-Operative Pain and Reduce or Eliminate Opioid Use
4/19/2023
Cali Biosciences Co., Ltd. announced it has initiated Phase III studies of its core product, CPL-01, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month.
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Blue Earth Diagnostics Highlights Upcoming Presentation of Additional Results from Investigational Phase 3 SPOTLIGHT Study of PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer
4/19/2023
Blue Earth Diagnostics Highlights Upcoming Presentation of Additional Results from Investigational Phase 3 SPOTLIGHT Study of PET Imaging Agent 18 F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer.
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A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
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First Patient Enrolled in Phase 3 Clinical Trial Evaluating ARINA-1 in Lung Transplant
4/18/2023
Renovion, Inc. today announced that the first patient has been enrolled in a Phase 3 clinical study evaluating ARINA-1, an investigational nebulized therapy to prevent the progression of bronchiolitis obliterans syndrome (BOS) progression in individuals with a bilateral lung transplant.