Refine by
Clinical Regulations Articles & Analysis
48 news found
While medical AI has many potential benefits, there are challenges that have not been tackled yet. One of the major challenges is the limited generalizability of many AI algorithms. Applying a medical AI algorithm that is trained in hospital A may give unexpected results when applied in hospital B. Why does this happen? Certain parameters are different between hospitals. If hospital A has Siemens ...
Vancouver, British Columbia – (January 11, 2023) – BioMark Diagnostics Inc. (“BioMark” or the “Company”) (CSE: BUX) (FSE: 20B) (OTCMKTS: BMKDF) an advanced stage liquid biopsy company with a focus on hard to detect and treat cancers is pleased to announce several updates from ongoing clinical trial using the Company’s liquid biopsy test for ...
Highlights Discussions held with US and EU Regulators and Clinical Key Opinion Leaders Proposing two Phase 3 studies in two major surgery types to aim to provide a broad surgery label for XF-73 Nasal Phase 3 programme will deliver an approvable data package for both US and EU authorities. ...
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 ...
In-person clinic appointments are offered only to those unable to complete remote assessments. ...
Observed only mild and transient adverse events, with no use of emergency epinephrine Observed 98.4% patient compliance to date with novel OMIT therapeutic modality Safely started patients on dose 4, potentially reducing the time to reach maintenance by several weeks NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology ...
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 ...
Positive effects on oxygenation observed with the 2.5 mg/kg dose at the end of the exercise interval Positive effects on post-exercise recovery based when comparing measurements 10 min post-exercise to measurements at the end of the exercise interval TSC was safe and well-tolerated by all subjects with no serious adverse events reported Diffusion Pharmaceuticals Inc.(NASDAQ:DFFN) ...
ByCervoMed
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 ...
AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a shared purpose to free people from a lifetime of genetic disease, today reported financial results for the first quarter ended March 31, 2022 and provided a business update. “This is an important year for AVROBIO with key milestones that we believe will elevate the company profile and drive significant value ...
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 ...
Transgene will discuss new immunogenicity and clinical data generated with TG4050 that reinforce the strong potential of this individualized immunotherapy: Relevant neoantigens could be identified in all evaluable patients and TG4050 induced tumor specific T cell responses against multiple of these patient-specific neoantigen targets. Early signs of clinical activity were observed with ...
Partnership will Make Guardant Health Cancer Tests Available to Over 250 Million Patients with a Record in Epic Integration Will Simplify the Process for Clinicians to Order Tests and Access Results Directly in the Patient Record REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a partnership with Epic, the ...
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 ...
“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 ...
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 ...
The Company plans to initiate clinical investigation of FT536 as a monotherapy and in combination with tumor-targeting monoclonal antibody therapy for the treatment of multiple solid tumor indications. ...
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 ...