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.
New Publication Validates Performance of Natera’s Signatera™ MRD Test in Ovarian Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian...
ONWARD Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home
ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), reported topline results from the LIFT Home study, evaluating the safety and...
Connect Biopharma Reports CBP-201 Achieved All Primary and Key Secondary Endpoints in Pivotal Atopic Dermatitis (AD) Trial in China
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced topline results for the primary analysis population of...
PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA®
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food...
Accuray Announces First CyberKnife® Systems in Africa, Providing a New Option and Hope for Potentially Life-Saving Radiation Treatments for More Cancer Patients
Accuray Inc.(NASDAQ: ARAY) announced the company is expanding its global footprint with the introduction of its CyberKnife® platform in Africa, making it possible for more patients to obtain access to the extremely precise stereotactic radiosurgery (SRS) and...
Multilingual Clinical Trial Translations: How Language Access Can Drive Recruitment and Retention of Diverse Participants
As we started to explore in our latest Clinical Trial Corner post, multilingual clinical trial translations are an essential instrument enabling recruitment of racially and ethnically diverse populations as recommended by the US Food and Drug Administration (FDA) in...
Idera Bolsters Rare Disease Portfolio with Aceragen Buyout
Two rare disease companies - Idera Pharmaceuticals and Aceragen - are merging to pursue the common goal of an FDA approval that could come as early as 2024. For Idera, the merger is something of a lifeline after its top drug candidate flopped last year. On the other...
CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas (CTCL)
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation...
Foresight Diagnostics Patent Issued for Minimal Residual Disease Detection Technology
Foresight Diagnostics, Inc, a leader in cancer diagnostics and cancer relapse testing, announced that the U.S. Patent and Trademark Office (USPTO) has granted the company patent No.11,447,833 for the detection of minimal residual disease (MRD) using its personalized...
Sorrento Therapeutics Completes Enrollment of Phase 2 Clinical Trial of Resiniferatoxin (RTX) for Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced that the company has completed enrollment of its latest Phase 2 clinical study of RTX for treating moderate-to-severe osteoarthritis of the knee pain (OAK). This Phase 2 study follows the analysis of the...
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