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.Medical Record Translations: Why Multilingual Patient Records Are Necessary in Medicine Today
As heighted numbers of patients seek medical care in overseas markets and companies look to recruit patients from all walks of life, what role do accurate medical record translations play in enabling health care professionals to deliver more targeted, patient-focused...
Light at the End of Long Road as FDA Greenlights Novavax Vaccine
The U.S. Food and Drug Administration granted Novavax’s COVID-19 vaccine Emergency Use Authorization (EUA) after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older. On June 7, the FDA’s Vaccines and...
Providence Therapeutics Signs Licensing Agreement with SickKids for Immunotargeting Technology
Providence Therapeutics, Canada's premier mRNA medicines company, is pleased to announce that it has entered into an exclusive licensing agreement with The Hospital for Sick Children (SickKids) of Toronto, ON, for an immunotargeting technology platform. This platform...
Marrone Bio Innovations, Inc. Shareholders Approve Merger Agreement with Bioceres Crop Solutions Corp.
Marrone Bio Innovations, Inc. (MBI) announced that during a special shareholder meeting held on July 8, 2022, its shareholders approved a proposal to adopt the previously announced Agreement and Plan of Merger (Merger Agreement), dated as of March 16, 2022, by and...
Rational’s Experimental Herpes Vaccine Shows Preclinical Promise
Rational Vaccines' experimental vaccine candidate for herpes simplex virus type 2 (HSV-2), the primary cause of genital herpes, is showing promise in preclinical studies. Massachusetts-based Rational Vaccines said findings from a pilot study funded by the National...
BioSig Announces Purchase Agreement with Kansas City Heart Rhythm Institute at Overland Park Regional Medical Center
BioSig Technologies, Inc. ("BioSig" or the "Company"), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, announced that Kansas City Heart Institute...
Eyenovia Strategic Partner Arctic Vision Enrolls First Patient in Phase III Clinical Trial of ARVN003 (MicroLine) for Presbyopia in China
Eyenovia, Inc., an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, announced that its strategic partner, Arctic Vision, a China-based biotech company concentrated on innovative ophthalmic...
FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial
Vertex Pharmaceuticals announced Tuesday that the U.S. Food and Drug Administration has withdrawn its clinical hold on the company’s Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID). The lift on the...
Provention Bio Announces FDA Extension of Diabetes Drug Review
Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the...
Quality Assurance for Medical Translations: Back Translation for Patient Diaries
Nuance, culturally specific idioms, and unique terminology are part of any language, but in an industry where mistranslations could endanger human life, how does back translation ensure high-quality translation of patient diaries? In healthcare, patient diaries are...
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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