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Clinical Trial Label Design Articles & Analysis: Older
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SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced an update from the Company’s work with biopharma company Boundless Bio. SOPHiA GENETICS first partnered with Boundless Bio in 2022 to develop and deploy Boundless Bio’s extrachromosomal DNA (ecDNA) detection algorithm as a clinical trial device, to ...
The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims to uncouple efficacy from ...
ByBayer AG
Airfinity announces today the launch of Airfinity IDA (Infectious Disease Analytics) 360, a new platform that will provide a comprehensive overview of vaccine and therapeutics candidates across the full infectious disease landscape. Airfinity IDA 360, a first-of-its-kind product in the health analytics market, will be a centralised source of competitive intelligence, providing clear and near ...
About the webinar 2020/21 led to significant clinical trial innovation in clinical trials in response to the Covid-19 pandemic with 2022 providing key insights, projects and lessons in the wider clinical trials space. 2023 will see these lessons merge with long-term trends and the lessons from important pilot programs to see wider use of innovative designs and methods. In this webinar, we look ...
ByStatsol
About the webinar In this free webinar, we focus on some of the most popular trial design topics covered this year. To see video, please click here In this free webinar you will learn about: Guide to Sample Size Re-estimation in Clinical Trials Unblinded Sample Size Re-estimation Sample Size for Complex Endpoints Sample Size for Win Ratio Statistic Sample Size for Win Ratio Statistic ...
ByStatsol
Phase 1 studies show improvement in cognitive factors, consistent with therapeutic potential of CY6463 to improve key features in neurological diseases CY6463 favorable tolerability and safety profile was confirmed Ariana Pharma, a leading Artificial Intelligence (AI) drug development company, in collaboration with Cyclerion Therapeutics, presented today safety and pharmacodynamic results ...
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) announced today that it has officially submitted the Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease (DED) to the U.S. Food and Drug Administration (FDA). If the FDA has no further comments after the 30-day review period, BRIM will proceed to initiate the Phase 3 clinical trial in December. Based on its ...
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) is pleased to announce that it has received agreement from the US Food and Drug Administration (FDA) on the Phase 3 clinical trial design for its lead candidate for Dry Eye Disease (DED), BRM421, at the End of Phase 2 Meeting. BRIM will submit the Phase 3 study protocol to the FDA in Q4 2022. Dr. Haishan Jang, Chair and CEO ...
Ariana Pharma, the leading Al-driven precision medicine company, has announced the first comprehensive blarcamesine pathway analysis impact using extensive data from the ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia (PDD) clinical study. Initial results were presented by Ariana Pharma at the Alzheimer’s Association International Conference (AAIC 2022) in San Diego, in ...
BRIM Biotechnology, Inc. (BRIM, TPEx 6885) reports that the Company’s Board of Directors has approved a proposal for a seasoned equity offering, following its recent emerging stock market (ESM) listing, to increase capital and advance its lead drug candidate, BRM421, to late-stage clinical trials for dry eye syndrome (DES). The Board of Directors gathered for an interim meeting today to ...
About Flamingo-01 and GLSI-100 Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant ...
Following site activation, patients will be screened, tested for HLA type, randomized, and enrolled into any of 3 clinical trial arms, and treatment of the first patients will begin. Certain aspects of each arm will be open label, and the 3rd arm exploring HLA types that are not HLA-A02 will be entirely open label. ...
Ariana Pharma, the leading eXplainable Artificial Intelligence (xAI) drug development company, announce the appointments of Dr. Marion Soto as Vice President, Business Development and Bertrand Lellouche as Chief Financial Officer. The financial and commercial experience of Marion and Bertrand will further drive Ariana’s accelerated growth. Marion and Bertrand will be bringing their ...
Kallyope, Inc., a leading biotechnology company focused on identifying and developing therapeutics involving the gut-brain axis, today announced the promotion of Shirly Pinto, Ph.D., to Chief Scientific Officer and the appointments of Jiajun Liu, Ph.D., as Vice President and Head of Biometrics and Michael Crutchlow, M.D., as Vice President and Head of Translational Medicine. ...
Ariana Pharma and OmiCure announce their collaboration with the renowned CLB Cancer Center to apply OmiCure and Ariana Artificial Intelligence (AI) capabilities to find more efficient treatments for cancer patients. The data were communicated at ASCO 2022 last week and showed that Artificial Intelligence RNA-based therapeutic recommendations have the potential to expand personalized cancer ...
CIRM grant awarded to accelerate clinical trial of NRTX-1001, a promising regenerative neuronal cell therapy in adults with drug-resistant seizures NRTX-1001 is the first human cell therapy candidate to enter clinical investigation for the treatment of epilepsy Neurona Therapeutics, a clinical-stage biotherapeutics company ...
(Nasdaq: AFMD), (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that three abstracts of clinical trial designs of its AFM24 innate cell engager (ICE®) have been published and will be ...
FDA review of manufacturing plans and pharmacy procedures associated with a recently placed clinical hold on the FLAMINGO-01 phase III clinical trial is underway with formal feedback from the FDA expected shortly. Greenwich is prepared to address FDA manufacturing and pharmacy procedure hold issues so that FLAMINGO-01 can commence as soon as possible. Negotiations of clinical trial contracts ...
RMAT designation enables early interactions with the FDA to discuss clinical trial design and other actions to expedite development and review. ...
ByKalaris
NRTX-1001 is being evaluated in a Phase 1/2 clinical trial in people with drug-resistant mesial temporal lobe epilepsy. ...