Clinical Trials (Phase III)
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After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions. -
Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome. -
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners. -
Scholar Rock to Present New Data Evaluating Apitegromab at 36 Months from the Phase 2 TOPAZ trial at the 2023 Annual Cure SMA Conference
5/8/2023
Scholar Rock announced today it will present extension data from the Phase 2 TOPAZ trial evaluating patient outcomes after 36 months of treatment with apitegromab.
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Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week® 2023
5/8/2023
Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week ® 2023.
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Acasti Successfully Submits Pivotal GTX-104 Phase 3 Safety Study Protocol with FDA and Implements Strategic Realignment Plan That Extends Projected Cash Runway Through Calendar Q2 2025
5/8/2023
Acasti Pharma Inc. today announced the successful submission to the FDA of GTX-104's full protocol of its pivotal Phase 3 Safety Study and implementation of a strategic realignment plan to maximize shareholder value.
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Innovent Announces First Participant Dosed in Phase 3 Study (RESTORE) of IBI311 (Anti-IGF-1R Monoclonal Antibody) in Patients with Thyroid Eye Disease
5/8/2023
Innovent Biologics, Inc. announces that the first patient with Thyroid Eye Disease has been successfully dosed in the Phase 3 study of IBI311, a recombinant anti-insulin-like growth factor-1 receptor monoclonal antibody.
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Telix to Supply Bayer with Illuccix® for Global Phase III Prostate Cancer Study
5/7/2023
Telix Pharmaceuticals Limited announces that it has entered into an agreement with Bayer AG to supply Illuccix® [1] for the Phase III ARASTEP study.
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During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy. -
The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas. -
FibroGen Announces Results for MATTERHORN, a Phase 3 Clinical Study of Roxadustat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)Study Did Not Meet Primary Endpoint
5/5/2023
FibroGen, Inc. (NASDAQ: FGEN) today announced that MATTERHORN, a Phase 3 clinical study of roxadustat for treatment of anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (MDS) did not meet its primary efficacy endpoint.
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While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi. -
Data from Phase III confirmatory MIRASOL trial show antibody-drug conjugate boosts survival in platinum-resistant ovarian cancer, setting the stage for full approval by the FDA.
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Visus Therapeutics Presents Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL™ PF for the Treatment of Presbyopia at Eyecelerator @ ASCRS 2023
5/4/2023
Visus Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing multi-targeted ophthalmic therapies for indications in the front and back of the eye, today presented key topline data from the pivotal Phase 3 BRIO-I clinical trial.
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Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
5/4/2023
Veru Inc. (NASDAQ: VERU) today announced that in an April 27, 2023 meeting, the Company and FDA reached agreement on the design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin treatment in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS) and the path forward to submit a new Emergency Use Authorization (EUA) application and/or New Drug Application (NDA).
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The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter. -
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis. -
Summit Therapeutics Announces Initial Indications for Clinical Trials for Ivonescimab (SMT112)
5/3/2023
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has determined its first two indications in non-small cell lung cancer (NSCLC) in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab.
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PharmaEssentia Initiates Phase 3b Trial of Ropeginterferon alfa-2b-njft Investigatng New Dosing Regimen for Patients With Polycythemia Vera (PV)
5/3/2023
PharmaEssentia USA Corporation today announced that the first patients are now being dosed in ECLIPSE PV, a Phase 3b clinical study evaluating an accelerated dosing schedule for ropeginterferon alfa-2b-njft using a prefilled syringe for the treatment of adults with polycythemia vera (PV).
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Taiho Oncology and Servier Announce Publication in the New England Journal of Medicine of Pivotal Phase 3 Data for Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer
5/3/2023
Taiho Oncology, Inc. and Servier today announced the publication of results from the pivotal Phase 3 SUNLIGHT* clinical trial of trifluridine/tipiracil (LONSURF®), alone or in combination with bevacizumab, in refractory metastatic colorectal cancer (mCRC) in the May 4, 2023, issue of the New England Journal of Medicine (NEJM).