clinical trial design News
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Clinical Trial Design Trends for 2023
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 ...
By Statsol
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Clinical Trial Design - This year`s most popular topics
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 ...
By Statsol
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BRIM Biotechnology Board of Directors approves seasoned equity offering of USD 18 million to accelerate phase 3 development of lead asset BRM421 for dry eye syndrome
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 ...
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Cellphire Therapeutics Names W. Allan Alexander, MD as Chief Medical Officer
Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic cellular therapeutics announced today the appointment of W. Allan Alexander, MD as the company’s Chief Medical Officer, effective immediately. “Allan joining the team is an important milestone for Cellphire,” said Mike Gaffney, Chief Executive Officer. “His deep ...
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BRIM Biotechnology receives FDA agreement on Phase 3 clinical trial design for BRM421, BRIM’s lead candidate for Dry Eye Disease, at End of Phase 2 Meeting
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 ...
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Alkahest to Present New Data from Phase 2a Study in Mild-to-Moderate Alzheimer’s Disease at the Clinical Trials in Alzheimer’s Disease (CTAD) Conference
Alkahest Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases, today announced an oral presentation of data from its phase 2a study ALK6019-201 in mild-to-moderate Alzheimer’s Disease at the 12th Clinical Trials on Alzheimer’s Disease from December 4 – 7, 2019 in San Diego. Presentation details ...
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Ariana announces an Artificial Intelligence-driven Precision Medicine collaboration with Sanofi
Ariana® Pharma a leading Artificial Intelligence drug development company announced today that it has entered into an Artificial Intelligence-driven Precision Medicine collaboration with Sanofi and leading academic partners targeting autoimmune and inflammatory diseases associated with primary immune deficiencies. The ATRACTion project will generate clinical, multi-omic (single cell RNA ...
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Vaccitech Doses First Patient in HPV001, a Phase 1/2 Clinical Trial of VTP-200 Immunotherapeutic for High-risk Persistent HPV Infection
Vaccitech Ltd, a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, today announced the dosing of the first patient as part of the HPV001 clinical study. HPV001 is a randomized, placebo-controlled Phase 1/2 clinical trial designed to evaluate the safety and ...
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Sight Sciences Announces First Patient Treated in TRIDENT European Trial to Evaluate the OMNI® Surgical System in Pseudophakic Eyes with Open-Angle Glaucoma
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, today announced that the first patient has been treated in the novel TRIDENT clinical trial, designed to demonstrate the OMNI Surgical System with higher volume as a safe and effective standalone treatment option, compared to ...
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Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device ...
By Nyxoah SA
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Ariana appoints pharmaceutical industry drug development veteran
Ariana, a leading eXplainable Artificial Intelligence (AI) drug development company, is delighted to announce the appointment of Dr. Hichem Chakroun as Executive VP, Clinical Development. As EVP, Hichem will apply his industry expertise and experience to help accelerate the strategy of Ariana in the clinical trials setting. Prior to joining Ariana, Hichem was Director of Development Operations ...
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Synairgen provides update on ACTIV-2 Trial
Synairgen plc (LSE: SNG), the respiratory company developing SNG001, a formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces that the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) has halted all patient recruitment in its Phase 2/3 COVID-19 trial (Protocol ACTIV-2/A5401; ...
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Neurona Therapeutics to Present New Preclinical Data and Clinical Trial Plans for Lead Neural Cell Therapy Program, NRTX-1001, at the Annual Meeting of the American Epilepsy Society
Data from IND-enabling studies show accurate delivery, targeted biodistribution, favorable safety profile, durable suppression of seizures and reduction in disease pathology A first-in-human Phase 1/2 clinical trial of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy has been initiated and will begin recruiting soon Neurona Therapeutics, a clinical-stage biotherapeutics ...
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Kallyope, Pioneers in Drug Discovery via the Gut-Brain Axis, Advances Discovery and Development Teams with New Appointments
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. ...
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BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2021 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2021 with the Securities and Exchange Commission. Q2 and Recent Business Highlights: ...
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BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA
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 ...
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Rubius Therapeutics to Present Trials in Progress Poster for the Phase 1/2 Clinical Trial of RTX-224 in Select Advanced Solid Tumors at the 2022 American Society of Clinical Oncology Annual Meeting
Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics™ for the treatment of cancer and autoimmune diseases, today announced that the Company will present a Trials in Progress poster presentation for its second broad immune ...
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Adaptimmune Updates Data from its Phase 1 Trial for Liver Cancer at ILCA Showing Clinical Benefit
One complete response, and a disease control rate of 64% with stable disease for ≥16 weeks in two patients, as of the data cutoff Data presented today at the International Liver Cancer Association meeting at 12:25 p.m. CET Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 ADP-A2AFP trial for patients with liver ...
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Rubius Therapeutics to Present Trials in Progress Poster on the Phase 1 Clinical Trial of RTX-321 for HPV 16-Positive Cancers at the 2021 American Society of Clinical Oncology Annual Meeting
Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics™, today announced that the Company will present a Trials in Progress poster presentation for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, at the American ...
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Molecular Health and collaborators prove new analytical approach that leverages real-world data to anticipate molecular causation of adverse drug reactions
“We have established an approach that transforms real-world, in-human treatment outcomes and safety data into extensive datasets to better characterize desirable and undesirable interactions between molecular pathways and drugs,” explains Dr. David Jackson, Chief Innovation Officer at Molecular Health and co-author on all three articles. “The studies demonstrate a standardized ...
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