Clinical

ADaM: The Unsung Hero of Clinical Trial Data Analysis
  1. Clinical

ADaM: The Unsung Hero of Clinical Trial Data Analysis

IntroductionImagine you’re a researcher working on a groundbreaking clinical trial. You’ve collected mountains of data, but now comes the hard part—making sense of it all. Enter ADaM, the Analysis Data Model developed by CDISC. ADaM is the unsung hero that transforms raw data into actionable insights, ensuring your trial meets regulatory standards and delivers reliable […]
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  1. Clinical

Accutar Biotechnology Receives FDA Fast Track Designation for AC699 in ER+ / HER2- Breast Cancer

CRANBURY, N.J.–(BUSINESS WIRE) Aug 14, 2024 –Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, announced today that the US Food and Drug Administration (FDA) has granted the investigation of AC699 a Fast Track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen […]
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  1. Clinical

Prota Therapeutics Announces Publication in Allergy of Long-Term Peanut Allergy Study Confirming Clinical Remission as the Optimal Treatment Outcome

MELBOURNE, Australia, Aug. 14, 2024. Prota Therapeutics Pty Ltd (Prota), an Australian clinical-stage biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced publication in the journal Allergy of the first long-term study directly comparing remission and desensitization endpoints following food allergen oral immunotherapy (OIT). The Phase […]
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  1. Clinical

Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Clinical Trial of Reproxalap

LEXINGTON, Mass.–(BUSINESS WIRE)–Aug. 8, 2024– Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational […]
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  1. Clinical

First Patients Enrolled in US Pivotal Study of AI-Based Image Analysis Module for Lung Cancer

SANTA CLARA, Calif., Aug. 9, 2024. Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today the enrollment of the first patients in a US pivotal study of its AI-based image analysis module for lung cancer. The ON-SITE study, a multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial […]
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  1. Clinical

WestGene to Advance Clinical Trials Following Dual IND Approvals for World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine

CHENGDU, China, Aug. 8, 2024. WestGene Biopharma is proud to announce that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China’s National Medical Products Administration (NMPA) and the US FDA. This unprecedented achievement marks the world’s first IND-approved mRNA vaccine for EBV-related cancers in both the United States and China. On […]
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  1. Clinical

Turn Therapeutics Topical Atopic Dermatitis Candidate Significantly Inhibits Key Cytokines in Expansion Study of Flagship Formula

WESTLAKE VILLAGE, Calif., Aug. 5, 2024. Turn Therapeutics, a pharmaceutical and medical device company focused on immunology, advanced wound care, and dermatology, announced today positive data results of GX-03 in a biomarker study intended to measure its immunological inhibitory effects during eczema induction. The study evaluated the immunological inhibitory effects of the topical application of […]
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  1. Clinical

Innovent and SanegeneBio Announce First Participant Dosed in a Phase 1 Clinical Trial of IBI3016

SAN FRANSCISO and SUZHOU, China, Aug. 1, 2024. Innovent Biologics, Inc. (“Innovent”), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) today announced the first participant has been successfully dosed in a […]
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  1. Clinical

Sage Therapeutics and Biogen Announce Topline Results from Phase 2 KINETIC 2 Study of SAGE-324 (BIIB124) for the Treatment of Essential Tremor

CAMBRIDGE Mass. – July 24, 2024 – Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB) announced topline results from the Phase 2 KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET). The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship […]
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  1. Clinical

NIH Researchers Discover Potential Therapeutic Target for Degenerative Eye Disease

July 26, 2024 — Researchers from the National Institutes of Health (NIH) have discovered the source of dysfunction in the process whereby cells in the eye’s retina remove waste. A report by scientists at NIH and Johns Hopkins University, Baltimore, details how alterations in a factor called AKT2 affects the function of organelles called lysosomes […]
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