Clinical Trials (Phase III)
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AstraZeneca reported Monday that adding Lynparza to Imfinzi improved outcomes in mismatch repair proficient endometrial cancer, more than doubling the median duration of response in patients.
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New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
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Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease
3/18/2024
Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI ® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease.
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Pharvaris Announces Phase 3 Clinical Study Design for Recently Initiated RAPIDe-3 Study, and Presents Quality-of-Life Improvement and Caregiver Behavior Data at Two Recent HAE Congresses
3/18/2024
Pharvaris, a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema attacks, presented at two recent congresses: the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema and the 2024 HAE International Regional Conference Americas.
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Phase III clinical trial of pediatric subjects with PMM2-CDG begins crossover to open label epalrestat
3/18/2024
Maggie's Pearl, a collaboration between Perlara, Maggie's Cure, and the Mayo Clinic, announced that the Phase III trial of oral epalrestat therapy in pediatric subjects with PMM2-CDG (formerly, Congenital Disorder of Glycosylation Type 1a) has been green-lighted to transition to open label.
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Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer
3/18/2024
Natera, Inc. announced a collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease -guided adjuvant treatment in stage II colorectal cancer patients.
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Photocure Partner Asieris announces positive international Phase III clinical trial results for Cevira and data presentations at the 2024 EUROGIN Congress and SGO Annual Meeting
3/18/2024
Photocure ASA, the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals has communicated the Phase III clinical study results for its non-surgical treatment candidate for cervical high-grade squamous intraepithelial lesions Cevira®.
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Mitsubishi Tanabe Pharma America Announces Publication of Positive Results from Phase 3 BouNDless Trial of Investigational ND0612 in People with Parkinson's Disease Experiencing Motor Fluctuations
3/18/2024
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of results in The Lancet Neurology from the pivotal, Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy, safety and tolerability of investigational ND0612.
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Intellia Therapeutics Announces First Patient Dosed in the Phase 3 MAGNITUDE Study of NTLA-2001 as a Single-Dose CRISPR-Based Treatment for Transthyretin Amyloidosis with Cardiomyopathy
3/18/2024
Intellia Therapeutics, Inc. today announced the first patient dosed in the global pivotal, Phase 3 MAGNITUDE trial of NTLA-2001.
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Positive RUBY phase III data show potential for Jemperli (dostarlimab-gxly) combinations in more patients with primary advanced or recurrent endometrial cancer
3/16/2024
GSK plc announced statistically significant and clinically meaningful overall survival results from Part 1 and progression-free survival results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial in adult patients with primary advanced or recurrent endometrial cancer.
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The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.
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Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting
3/14/2024
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today released positive topline clinical data from its Phase 3 pivotal pharmacokinetic (PK) clinical study of Anaphylm™ (epinephrine) Sublingual Film and findings from the FDA Type C meeting.
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First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline
3/14/2024
First Wave BioPharma, Inc. announced it has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple, late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase 3-ready, targeted, oral biotherapeutic for celiac disease.
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AstraZeneca announces initiation of THARROS – a Phase III clinical trial investigating the potential of BREZTRI to improve cardiopulmonary outcomes in people with COPD
3/13/2024
AstraZeneca today announced the initiation of a Phase III trial to investigate the potential effect of triple-combination inhaled therapy BREZTRI AEROSPHERE®.
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Positive Feedback From the EMA and FDA on Alzprotect's Phase 2b/3 Development Strategy for PSP
3/13/2024
ALZPROTECT is thrilled to announce that it has received favorable feedback from both the American and European authorities regarding the regulatory path for advancing the clinical development of Ezeprogind/AZP2006 for patients with PSP.
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Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023.
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BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study
3/12/2024
BioCardia, Inc. announced Centers for Medicare & Medicaid Services approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.
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89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis
3/12/2024
89bio, Inc. today announced the initiation of its Phase 3 ENLIGHTEN Program evaluating the efficacy and safety of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH).
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Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
3/12/2024
Pfizer Inc. announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS® in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma showed a statistically significant and clinically meaningful improvement in overall survival compared to lenalidomide and rituximab plus placebo.
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NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD
3/12/2024
NewAmsterdam Pharma Company N.V. announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia and/or Atherosclerotic Cardiovascular Disease or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.