Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Researchers Link Mutations in Long Neglected Non-Coding Genome to Cancer
Researchers from the Dana-Farber Cancer Institute have found a way to examine more closely into a long-neglected, non-coding portion of the human genome, uncovering mechanisms that might drive or suppress cancer development. Since scientists at the Human Genome...
Rune Labs Secures FDA Clearance for Parkinson’s Disease Monitoring through StrivePD Ecosystem on Apple Watch
Rune Labs, a precision neurology company, announced its StrivePD software ecosystem for Parkinson's disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to gather patient symptom data through quantifications made by Apple Watch. By...
GSK Headed to Regulators with RSV Vaccine
The pursuit for an effective vaccine against the respiratory syncytial virus (RSV) may be at an inflection point. GlaxoSmithKline disclosed positive headline data Friday from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine. The...
Degron Therapeutics Launches into Sizzling Hot Protein Degradation Space
Shanghai-based biotechnology company Degron Therapeutics announced that it has secured $22 million in Series A financing for its unique molecular glue-based targeted protein degradation platform GlueXplorer. Degron plans to use the funds generated from this round of...
Vertex Kidney Disease Drug Scores FDA Breakthrough Therapy Designation
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment...
Seres Touts Strong Phase III Results Against Recurrent C. Difficile Infection
Massachusetts-based Seres Therapeutics, Inc. announced Tuesday that its Phase III Ecospor IV study exhibited a strong safety profile in addition to statistically significant positive results. The study utilizes an open-label design to determine the potential of...
Pear Therapeutics Announces New Analysis Showing Reduction in Healthcare Resource Utilization and Associated Costs in Patients Using reSET® at Six Months
Pear Therapeutics, Inc., the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs), announced a manuscript accepted for publication and available via pre-print of a real-world study displaying reduced...
Legend Biotech Announces U.S. FDA Clearance of IND Application for Solid Tumor CAR-T, LB1908 for Relapsed or Refractory Gastric, Esophageal and Pancreatic Cancers
Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND)...
Culturally Appropriate Translations for Your Target Audience: In-Country Review (ICR) for Quality Medical Translations
In an industry where mistranslation could put a life at risk, why is it important for language service providers (LSP) to leverage in-country review (ICR) for quality medical translations? When translating medical documents like patient medical records, medication...
Global Roundup: Memo Therapeutics Takes Aim at BKV Infections
Memo Therapeutics, a Switzerland-based antibody discovery and development company, initiated a Phase I study that will evaluate intravenous doses of the experimental MTX-005 that targets BK polyomavirus (BKV) infection in renal transplant patients. The study will...
Categories
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com