clinically designed 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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Microbiotica`s Live Bacterial Therapeutic, MB097, in development to begin clinical trials in 2022 in immuno-oncology
MB097 is a consortium of bacteria at the core of the microbiome signature predictive of patient response to Immune Checkpoint Inhibitor therapy Data show potent anti-tumour efficacy in vivo and in vitro MB097 is in manufacturing process development for Ph1b study expected to start next year MB097 is the first microbiome precision medicine in immuno-oncology, clinically designed in the same ...
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Justine Han of APS named Runner-up in Jefferson’s 2nd Annual JAZTank Competition
Congratulations to Justine Han of APS, runner-up of Jefferson's 2nd Annual JAZTank Competition on April 27, 2016. Her presentation on plasma treatment of corneal ulcers earned: Cash: $5,000 in financial support Business Mentorship: Six months of shared (between the two runners up) workspace at Militia Hill Ventures, a life sciences innovation hub that provides physical space where companies, ...
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GI Innovation signed a contract with Medirama for joint research development of next generation innovative immuno-oncology
-GI Innovation-Medirama forms a ‘Joint Development Committee’ for professionalism maximization -Joint development for two new immuno-oncology… partial shared cooperative model of commercialization revenue GI Innovation, an innovative new drug development company signed a contract with Medirama, clinical development specialized company for joint research development of next ...
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ABK Biomedical Inc. Raises $30M USD in Series B Financing
ABK Biomedical, Inc., a medical device company dedicated to the research, development and commercialization of innovative embolic therapies, announced a $30 million USD Series B financing. The round is co-led by F-Prime Capital and Varian Medical Systems. ABK Biomedical will use the funding for continued focused product development of its Eye90 microspheres™, which are designed for ...
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Microbiotica’s Live Bacterial Therapeutic, MB097, in development to begin clinical trials in 2022 in immuno-oncology
Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, today announces that MB097 is now in pre-clinical development for treatment of patients not responding to anti-PD1 therapy. Clinical trials are due to begin in 2022. MB097 is clinically designed and experimentally validated. Studies have shown that the gut microbiome plays a critical and causative role in determining ...
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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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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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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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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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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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Puzzle Medical announces partnership with MMC Medical for clinical developments
Puzzle Medical is delighted to announce our partnership with MMC Medical International Services for Puzzle Medical Devices' upcoming clinical developments. MMC is committed to its clients' clinical trials from protocol and trial design through the entire cycle of execution and study publications. Sharing nearly 30 years of industry and broad clinical experience MMC takes pride in supporting the ...
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NewGen Surgical Earns USDA Certified Biobased Label On All Products
NewGen Surgical Inc. announced today that it has earned the U.S. Department of Agriculture (USDA) Certified Biobased Product label on all product lines. Managed by the U.S. Department of Agriculture (USDA), the BioPreferred Program is an initiative created by the 2002 Farm Bill (and recently reauthorized by the 2018 Farm Bill), to increase the development, purchase, and use of biobased products. ...
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Pascal Biosciences First to File Patent for COVID-19 Antiviral Activity with CBD
VANCOUVER, BRITISH COLUMBIA, April 21, 2022- Pascal Biosciences Inc. (“Pascal” or the “Company”) (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF) was the first to report cannabinoids can kill SARS-CoV-2, the virus that causes Covid-19. Pascal filed an international patent covering this work prior to the press release in July 2020, and now it is clear that Pascal was the first to file ...
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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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Bluewind Medical Ltd. Completes OASIS Study Patient Enrollment
Bluewind Medical, Ltd., developer of the innovative RENOVA iStim implantable neuromodulation device for treatment of urinary urgency incontinence, today announced the successful completion of patient enrollment in the OASIS pivotal clinical study that will be the basis by which the company will seek US-FDA (Food & Drug Administration) marketing clearance in the United States. OASIS is a ...
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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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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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NeoTherma Oncology Grows Engineering Leadership Team - WICHITA, Kansas
NeoTherma Oncology (NTO) announces they have expanded their leadership team with key senior staff who will advance the development and commercialization of the VectRx System. NTO’s new additions include: Ken Belt, Chief Engineer: Ken will lead RF design, and has 48 years of experience in the medical device field with extensive experience in MRI coil and phased array engineering. ...
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