clinical trial regulations News
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Cell and Gene Therapy Industry Comes Together for Matica Bio’s New Global Event
Matica Biotechnology, Inc. (Matica Bio), a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, hosted an inaugural event this week, Global Cell & Gene Day, with CHA Medical & Bio Group, providing a specialized venue for learning, innovation and networking for the advancing cell and gene therapy ...
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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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RECELL System Vitiligo Clinical Trial Protocol to be Presented at the Global Vitiligo Foundation Annual Scientific Symposium
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that an abstract highlighting the clinical trial protocol utilizing the RECELL® Autologous Cell Harvesting Device (RECELL® System) to treat vitiligo will ...
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Mojo Vision Working with FDA, Nonprofit Organization to Assist People with Low Vision
SARATOGA, Calif.--(BUSINESS WIRE) https://www.businesswire.com/news/home/20200116005187/en/Mojo-Vision-Working-FDA-Nonprofit-Organization-Assist --Mojo Vision, the Invisible Computing company, today announced a pair of initiatives integral to its goal of assisting people with low or impaired vision. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Mojo ...
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FB2001 (Bofutrelvir) Phase II/III Clinical Trial Protocol Approved by NMPA
Frontier Biotech (stock code: 688221.SH) announced that the Phase II/III clinical study protocol of FB2001 (generic name: Bofutrelvir) is approved by the Center for Drug Evaluation, NMPA. The study is a worldwide multi-center, randomized, double-blind and placebo-controlled Phase II/III trial to evaluate the safety and efficacy of Bufutrelvir for hospitalized Covid-19 patients. Frontier Biotech ...
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Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective ...
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RECELL System to be Highlighted at Upcoming Music City SCALE Multidisciplinary Dermatology Meeting
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that a discussion on the RECELL System will be held during the Symposium for Cosmetic Advances & Laser Education (SCALE) multidisciplinary ...
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AB2 Bio announces readiness for recruitment in pivotal Phase 3 trial of Tadekinig alfa, a novel human recombinant interleukin-18 binding protein, in children with genetic diagnosis of NLRC4-MAS mutation or XIAP deficiency, with amended design in the U.S.
AB2 Bio Ltd, a Swiss advanced clinical-stage biotech company, specialized in developing innovative therapies for the treatment of severe systemic autoinflammatory diseases, announced today that a single-arm open label design with a randomized withdrawal phase for its ongoing pivotal Phase 3 trial under an Investigational New Drug (IND) Application for its product candidate Tadekinig alfa, has ...
By AB2 Bio Ltd.
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Microvi and Nexilico Develop Powerful Computational Platform for Gut Microbiome funded by NIH
Under a National Institute of Health (NIH) grant awarded by the National Institute of General Medical Sciences (NIGMS), Microvi, Nexilico, and their research partners have developed a first-of-its-kind predictive computational platform focused on the gut microbiome and its interaction with therapeutics. The in silico platform reduces the cost and timeframe of drug development by reducing the ...
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Keeping our Patients and Colleagues Safe During the Ongoing COVID-19 Pandemic
At DiscGenics, we are actively monitoring developments in the ongoing coronavirus (COVID-19) pandemic and recommendations from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Utah Department of Health. As the situation continues to rapidly evolve, our top priority remains the health, safety and well-being of our employees and patients, their families, ...
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Kadimastem Receives Grant for a Total Budget of $3.1 million from the Israeli Innovation Authority
NESS ZIONA, ISRAEL, March 3, 2022 – Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, has received a grant from the Israel Innovation Authority (IIA) for a total budget of NIS 10 million ($3.1 million) and a net grant of NIS 4 million ($1.25 million). The funds will be used to advance the filing of an IND ...
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Cardiac Dimensions Reaches 1,000 Implants of Carillon System, a Minimally Invasive Treatment for Functional Mitral Regurgitation
Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the Carillon Mitral Contour System® has been implanted in 1,000 patients in the United States, Europe, Australia, Turkey and the Middle East. The Carillon System is a right-heart transcatheter mitral valve ...
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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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Broadening of COVIDITY Phase 1 clinical trial in South Africa
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces an update regarding the South African Health Products Regulatory Authority’s (SAHPRA) approval of a protocol amendment to the Phase 1 COVIDITY clinical trial being conducted at the University of Cape Town (UCT) Lung Institute in South Africa. The ...
By Scancell
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AI -driven analysis of Parkinson’s Disease Dementia clinical trial reveals potential molecular mechanism of blarcamesine (ANAVEX2-73) in restoring key neurodegenerative pathways
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 ...
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Anavex Life Sciences and Ariana Pharma present positive phase II clinical and biomarker data at the AD/PD 2022 International Conference
Ariana Pharma, the eXplainable Artificial Intelligence clinical development Company, announced today the presentation of Phase 2 clinical biomarker data from the ANAVEX2-73-PDD-001 Parkinson’s Disease Dementia (PDD) study at the AD/PD 2022 International Conference. MDS-UPDRS Total score improved significantly for patients treated with ANAVEX®2-73 high oral once-daily dose compared to ...
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CY6463 administration is linked to improvements in Alzheimer’s disease-relevant biomarkers, as revealed by eXplainable AI-driven analysis of multiple Phase 1 clinical trials ?
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 ...
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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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Celularity Reports First Quarter 2022 Financial Results and Provides Corporate Update
Ongoing Phase 1 study of unmodified placental-derived natural killer (NK) cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) continues enrolling new cohorts to reflect adjustments to treatment regimen and dosing as outlined in December 2021 Ongoing Phase 1 study of CYNK-001 in glioblastoma multiforme (GBM) U.S. Food and Drug Administration (FDA) granted Fast Track ...
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Ariana Pharma strengthens management team with appointments of VP Business Development and Chief Financial Officer
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 ...
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