Clinical Trials (Phase III)
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Novocure’s stock spiked more than 15% Wednesday morning after the company announced its Tumor Treating Fields therapy met the primary endpoint in a late-stage trial.
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While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.
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Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
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METIS Phase 3 Clinical Trial Met Primary Endpoint, Demonstrating a Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Metastases from Non-Small Cell Lung Cancer
3/27/2024
Novocure (NASDAQ: NVCR) today announced the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to supportive care alone in the treatment of patients with 1-10 brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery (SRS).
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Innovent Dosed First Participant in Phase 3 Clinical Study (Neoshot) of IBI310 (Anti-CTLA-4 Monoclonal Antibody) in Combination with Sintilimab for MSI-H/dMMR Colon Cancer Neoadjuvant Therapy
3/27/2024
Innovent Biologics, Inc. announces that the first participant has been successfully dosed with IBI310 in combination with sintilimab in a randomized, controlled, multicenter Phase 3 clinical trial, for resectable MSI-H/dMMR[1] colon cancer neoadjuvant therapy.
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argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease
3/27/2024
argenx SE announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjogren’s disease, following the analysis of topline data from the Phase 2 RHO study.
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Zai Lab Partner Novocure Announces METIS Phase 3 Clinical Trial Met Primary Endpoint, Demonstrating a Statistically Significant Extension in Time to Intracranial Progression for Patients with Brain Metastases from Non-Small Cell Lung Cancer
3/27/2024
Zai Lab Limited partner Novocure announced the phase 3 METIS clinical trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields therapy and supportive care compared to supportive care alone in the treatment of patients with 1-10 brain metastases from non-small cell lung cancer following stereotactic radiosurgery.
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Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.
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Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months
3/26/2024
Entera Bio Ltd. announced today that The American Society for Bone and Mineral Research (ASBMR) announced on March 25 2024 that the U.S. Food and Drug Administration (FDA) has communicated to the SABRE (Study to Advance BMD as a Regulatory Endpoint) project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
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Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine
3/26/2024
Moderna, Inc. announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine.
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United States Food & Drug Administration Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease
3/26/2024
Mesoblast Limited announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease.
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Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
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The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
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Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
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Syros Announces Completion of Enrollment of 190 Patients Necessary to Support Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial
3/25/2024
Syros Pharmaceuticals today announced that the enrollment of 190 patients has been completed in the SELECT-MDS-1 Phase 3 clinical trial evaluating tamibarotene in newly diagnosed higher-risk myelodysplastic syndrome.
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Cassava Sciences Announces Completion of an Interim Safety Review of Oral Simufilam On-going Phase 3 Trials
3/25/2024
Cassava Sciences, Inc today announced the completion of another interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease.
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Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy
3/25/2024
Axsome Therapeutics, Inc. announced that AXS-12, a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial.
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Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 Deficiency
3/25/2024
Andelyn Biosciences has partnered with Grace Science, LLC, to tech transfer and manufacture GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material for the treatment of NGLY1 Deficiency.
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Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.
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Biophytis Presented its Phase 3 Protocol in the Treatment of Sarcopenia
3/22/2024
Biophytis SA presented its phase 3 protocol aimed at demonstrating the potential of RuvembriTM in the treatment of sarcopenia at the International Conference on Frailty and Sarcopenia Research, held from March 20 to 22, 2024 in Albuquerque, NM, USA.