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Clinical Trial Regulations Articles & Analysis
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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 ...
Anywhere, Any Device, and Any Browser Access Researchers and clinical study teams can configure eDiaries specific to a trial as well as recurring or one-time assessments. ...
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 ...
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 ...
Matica Bio has extensive experience in the clinical and commercial production of cell and gene therapies and recently opened its new 25,000-square-foot GMP facility in Texas dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines. “Matica Bio understands the important ...
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 ...
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 ...
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 ...
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 ...
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 ...
ByScancell
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 ...
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 ...
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 ...
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) and Ariana Pharma (Cambridge, MA and Paris, France) today announced an artificial intelligence-driven, precision medicine collaboration. This collaboration is expected to identify biomarkers of response to refine patient selection to guide and accelerate the clinical development of Cyclerion’s investigational therapeutics for neurological and ...
Oral insulin program continues to advance with topline efficacy data expected in H2 2022 Significant value creation opportunities through oral COVID-19 vaccine program and partnerships Well positioned to capitalize on opportunities with strong cash balance of ~$174 million as of December 3, 2021 Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical ...
Protease inhibitor is a key component of Oramed’s PODTM technology that protects therapeutic proteins in the digestive system Oramed has already been granted this patent in the United States and Japan Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced the ...
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases, and help treat cancer, and HPV-associated diseases, announced today that eight company-sponsored presentations will be given this week at the 34th International Papillomavirus Conference (IPVC) , which is being held virtually from today, ...
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 ...
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 ...