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.
Patient Recruitment Translations: A Treatment for the Reputation Disparity in Clinical Trials?
How can patient-facing materials and patient recruitment translations facilitate recruitment of patients particularly to countries underrepresented in global drug development? As we discussed in our latest Clinical Trial Corner post, some countries and regions,...
Clinical Trial Corner: Assessment of Countries’ Reputation Among Sponsors of Industry Clinical Trials
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In the previous two-part Clinical Trial Corner miniseries, we provided a global assessment of patient diversity in industry CTs (iCTs)...
Neurocrine Biosciences Presents Additional Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at HSG 2022
Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In...
AbCellera’s First Program with Regeneron in Multi-Target Collaboration Advances in Preclinical Development
AbCellera (Nasdaq: ABCL) announced that Regeneron has elected to exercise its right to advance a therapeutic antibody candidate, discovered in partnership with AbCellera as part of a multi-target collaboration between the companies, into further preclinical...
Unity Bio Set to Launch Pivotal DME Study after Significant Data
Shares of Unity Biotechnology surged in early trading Tuesday following the company’s release of Phase II data showing a single injection of its experimental drug provided visual improvements in patients with diabetic macular edema. A single injection of UBX1325 led...
Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy
Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...
NeoGenomics Provides Update on MolDX Submission for CRC and RaDaR(TM) Commercial Launch
NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetics testing services and global oncology contract research services, is providing an update on its discussions with MolDX and on its commercial launch activities for RaDaRTM, its proprietary...
Aphaia Pharma Announces Enrollment of First Patient in Phase 2 Study of APH-012 for Chronic Weight Management in Individuals with Obesity
Aphaia Pharma, a clinical-stage biopharmaceutical company harnessing precision-targeted drug delivery technology for the treatment and prevention of metabolic diseases, announced that it has enrolled the first patient as part of a Phase 2 study evaluating the safety...
Anixa Biosciences Announces Commencement of Phase 1b Trial of its Breast Cancer Vaccine at Cleveland Clinic
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced the initiation of a Phase 1b trial for its preventative breast cancer vaccine. The study is being conducted at...
Pharmaceuticals Translations for Diverse and Emerging Market Clinical Trials
In our most recent Clinical Trials Corner post, we examined the lacking global representation of diverse patient populations in the development of new biopharmaceuticals when compared to consumption of developed drugs by country, highlighting the need to expand and...
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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