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.
Clinical Trial Corner: Patient Diversity in Clinical Trials Part 2, Assessing the Proportionality of Countries’ Participation In Pharmaceutical Development Relative to Their Consumption
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In the first part of my blog of this two part series on patient diversity in industry CTs (iCTs), I summarized the importance of the...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT2606, a Proposed Biosimilar of Nucala® (mepolizumab)
Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala® (mepolizumab), to US-sourced and...
Novavax COVID-19-Influenza Combination Vaccine Candidate Induced Antibody and T-Cell Responses Against SARS-CoV-2 and Homologous and Heterologous Influenza Strains
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination (CIC) vaccine...
Etiometry’s Clinical Decision-Support Software Receives CE Mark
Etiometry, a leader in clinical decision-support software for critical care, announced that the company has obtained the CE Mark under the European Union's medical device regulation, marking the second adult and third pediatric market authorization. Etiometry's...
PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced expanded interim data in the Phase 2 clinical trial investigating the...
Plexision completes development of PlexAPR™, a rapid blood test to predict transplant rejection
Plexision, a biotechnology company, which provides personalized diagnostic testing services for organ transplant patients has completed development of a six-hour blood test to predict organ transplant rejection - PlexAPR™. When combined with other clinical and...
Allogene Initiates First-Ever Phase II Trial of Allogeneic CAR-T Therapy
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in relapsed/refractory large B-cell lymphoma (LBCL). In addition to the ALPHA2 trial, the company...
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...
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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