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.
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...
FDA Pushes Designation Status for Cancer, Hemophilia Treatments
The U.S. Food and Drug Administration (FDA) is on a mission to recuperate from the review lag seen through the early phases of COVID-19 pandemic and has provided special designations for two treatments that could improve the lives of millions with recurrent...
Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder
Cybin Inc, a biopharmaceutical company focused on progressing effective therapeutics for patients, is submitting an Investigational New Drug application to the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003, a...
Exploring the Causal Connection Between COVID-19 and Diabetes
Research involving a causal link between COVID-19 and diabetes has surfaced in a study published in The Lancet Diabetes & Endocrinology in March. Researchers gathered results showing people who suffered from COVID-19 were 40% more likely than controls to develop...
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
Apyx Medical Corporation, a manufacturer of medical devices and supplies and the innovator of Helium Plasma Technology, marketed and sold as Renuvion® and J-Plasma® in surgical markets, today announced it has received 510(k) clearance from the U.S. Food and Drug...
FDA Hits Verrica With Third CRL For Lead Drug Candidate VP-102
Verrica Pharmaceuticals has obtained its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application for its molluscum contagiosum treatment candidate VP-102. The first CRL was distributed in July 2020 as the FDA...
Inaugural Patient Injected with Vaxinia, Cancer-Killing Oncolytic Virus
Imugene and City of Hope announced this week that the first patient has initiated treatment in a revolutionary Phase I clinical trial, which will evaluate the safety and efficacy of CF33-hNIS (Vaxinia), a cancer-killing virus, in adults with advanced tumors. The...
Altamira Therapeutics Receives Philippines’ FDA Approval of Bentrio Nasal Spray
Altamira Therapeutics Ltd., a company committed to developing therapeutics that address unmet medical needs, announced that Bentrio™ has been approved by the Philippines' Food and Drug Administration (FDA) and is now cleared for commercialization. The product will be...
Why Linguistic Validation for Patient Questionnaires is Important for Clinical Trials
With regulatory documentation presenting an enormous range of requisite communications and regulatory filings, why is linguistic validation for patient questionnaires such an important area of focus for international clinical trials? As an increasing number of...
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