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Clinical Regulatory Support Articles & Analysis
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Having earned a strong reputation for its expertise in GLP services, Protheragen-ING Lab offers a wide range of preclinical and clinical services to support drug development. The launch of Protheragen-ING Lab's medical device services marks a significant milestone in the company's evolution, further solidifying its position as a leader in the life sciences ...
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced a new partnership with Perigon Pharmacy 360, a full-service, specialty digital pharmacy, to enhance accessibility, affordability and adherence for patients treating symptoms of ADHD with Tris’ ...
Ingredients for muscle mass and post-workout recovery remain mainstays in sports nutrition, but the category is evolving and broadening. Ingredient examples are phospholipids for cognition and probiotic cultures for digestive health. “It’s very well-known that health is increasingly perceived holistically by consumers, especially younger demographics,” said Paige Wilkinson, ...
Daxor Corporation (NASDAQ: DXR), the global leader in blood volume measurement technology, today announces five new hospitals have implemented the Company’s BVA-100 blood volume diagnostic for clinical use to guide fluid management in heart failure patients during the first quarter of 2023. The addition of these hospitals contributes to the significant growth of blood volume analysis (BVA) ...
Ardigen, one of the world’s leading companies that utilizes artificial intelligence (AI) algorithms for drug discovery, is proud to announce that Mariola Fotin-Mleczek, PhD, has joined Ardigen’s Scientific Board. Her knowledge and experience will support a deeper understanding of active cancer immunotherapies in the drug discovery process provided by scientific innovation. Mariola ...
ByArdigen
Perimeter Medical Imaging AI, Inc. (TSX-V: PINK)(OTC: PYNKF) (FSE: 4PC) announced another commercial placement of its flagship Perimeter S-Series OCT system at a second hospital within one of the largest healthcare networks in North Texas, which is part of a major national healthcare system. Perimeter is a medical technology company driven to transform cancer surgery with ultra-high-resolution, ...
Following a US Food and Drug Administration (FDA) review of the first study, Destiny Pharma has completed further work developing both the dermal formulation and potential regulatory and clinical plans, which has cleared the path for progression into this second and final preclinical safety study. ...
In the process of drug development, the evaluation of drug effectiveness is one of the keys to determining whether prodrugs can sufficiently reach the market stage. BOC Sciences, as a professional contract research organization, can take care of the PROTAC in vivo evaluation workload for clients with a transparent project process and comprehensive evaluation reports to facilitate their PROTAC ...
“We are pleased that Cingulate has trusted Societal CDMO to carry out these essential activities to support CTx-1301 at such a critical juncture on its path through clinical development and toward ...
Iterative Health, formerly known as Iterative Scopes, a pioneer in precision-medicine technologies for gastroenterology, has announced a rebrand to reflect the company’s success in utilizing artificial intelligence (AI) to strengthen clinical research and augment clinical decision making within gastroenterology. In this new chapter, Iterative Health will continue to focus on its core ...
NeuroPointDX, a business unit of Stemina Biomarker Discovery, today announced the company will present recent data from the Children’s Autism Metabolome Project (CAMP), its large, comprehensive clinical study, supporting its precision medicine approach to the diagnosis and treatment of autism spectrum disorder (ASD) at the National TACA Autism Conference. CAMP is the largest clinical study ...
BioIntelliSense, a continuous health monitoring and clinical intelligence company, today announced its acquisition of AlertWatch®, an FDA-cleared, clinically proven patient monitoring solution. AlertWatch uniquely provides robust integration, data analysis and a patented intuitive display of contextual patient data for more efficient, actionable clinical decisions. As part of the recently ...
NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox. In recent weeks, randomized, placebo-controlled clinical trials were initiated in ...
Oncology informatics company, Inspirata, is pleased to announce the recent addition of a new key member to the company’s leadership team. Effective October 3rd, 2022, Laurie Smith has joined as Vice President of Product Strategy – Clinical Trial Matching. Laurie will be primarily focused on enhancing Inspirata’s suite of clinical trial matching solutions. This includes ...
Award to support Phase 1b studies to evaluate tau self-association small molecule inhibitor In August, company announced a $3.35M grant from NIH to support a Phase 1a clinical trial Oligomerix, Inc., a privately held company pioneering the development of small molecule therapeutics targeting tau for rare neurodegenerative and Alzheimer’s diseases, today announced an award of $2.49 ...
Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that a peer-reviewed paper has recently been published in Sleep and Breathing. The analysis, published by University of California San Diego investigators Dr. Brandon Nokes, Professor Atul Malhotra, and other collaborators, is based on a post-hoc analysis ...
Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) announced the commercial placement of its flagship Perimeter S-Series OCT system at a hospital that is part of a major national healthcare system and one of the largest healthcare networks in North Texas. Perimeter is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced ...
Creative Enzymes, the world’s leading diagnostic enzyme production company, has been committed to providing customers with various enzyme products and services for medical and research diagnosis. Relying on its professional team and the most advanced technology, as well as high-quality products and services, it has gained a solid reputation. Recently, Creative Enzymes launched a variety of ...
Target knockdown and safety results support continued clinical development Alnylam and Regeneron intend to initiate a Phase 2 study in late 2022 Detailed results to be presented at an upcoming medical congress CAMBRIDGE, Mass. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Sep. 15, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Regeneron Pharmaceuticals (Nasdaq: REGN) announced today ...
FBX-101 clinical data demonstrating safety and initial efficacy from the RESKUE trial is being presented at the 2022 Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium FBX-101 is a systemic AAV gene therapy following unrelated cord blood transplantation (“UCBT”) and has been well tolerated through Day 180 FBX-101 significantly increased GALC enzyme ...