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 […] Written by Admin February 4, 2025February 4, 2025 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 18, 2024August 18, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 15, 2024August 15, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 13, 2024August 13, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 11, 2024August 11, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 9, 2024August 9, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 7, 2024August 7, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 5, 2024August 5, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin August 2, 2024August 2, 2024 Saving Bookmark this article Bookmarked
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 […] Written by Admin July 31, 2024July 31, 2024 Saving Bookmark this article Bookmarked
Rising Serum Uric Acid Levels in US Teens In a comprehensive analysis spanning two decades, researchers have uncovered that serum uric acid (UA) concentrations and the prevalence of hyperuricemia have exhibited remarkable stability among adolescents in the United States. This longitudinal insight, meticulously documented in a recent study published in Pediatric Research, challenges prior assumptions about the possible upward trajectory of serum UA […] Written by Bioengineer June 20, 2025June 20, 2025 Saving Bookmark this article Bookmarked
More and more people missing from official data – State of the Planet Experts are warning that millions of people around the world aren’t being counted in census data, leaving policy makers in the dark about the populations they govern. They say a “quiet crisis” is unfolding with census data not being published due to concerns about declining response rates and the accuracy of data. In a paper […] Written by Columbia Climate School June 20, 2025June 20, 2025 Saving Bookmark this article Bookmarked
Rising Serum Uric Acid Levels in US Teens In a comprehensive analysis spanning two decades, researchers have uncovered that serum uric acid (UA) concentrations and the prevalence of hyperuricemia have exhibited remarkable stability among adolescents in the United States. This longitudinal insight, meticulously documented in a recent study published in Pediatric Research, challenges prior assumptions about the possible upward trajectory of serum UA […] Written by Bioengineer June 20, 2025June 20, 2025 Saving Bookmark this article Bookmarked
More and more people missing from official data – State of the Planet Experts are warning that millions of people around the world aren’t being counted in census data, leaving policy makers in the dark about the populations they govern. They say a “quiet crisis” is unfolding with census data not being published due to concerns about declining response rates and the accuracy of data. In a paper […] Written by Columbia Climate School June 20, 2025June 20, 2025 Saving Bookmark this article Bookmarked
Cluck once, and the river shakes: Inside the Amazon’s giant snake saga As a child, I was fascinated by reports and documentaries about field research and often wondered what it took to be there and what kind of knowledge was being produced. Later, as an ecologist, I felt the need for approaches that better connected scientific research with real-world contexts. I became especially interested in perspectives that […] Written by Admin June 19, 2025June 19, 2025 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked