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.
FDA Grants EUA for Point-of-Care COVID-19 Antibody Test
Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...
Paraxel Announces Resource for EU Clinical Trials Information System Regulation
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
Resurgence of COVID-19 Cases in European Cities Causes New Restrictions
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
Translating Lay Summaries – Driving Transparency
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Orphazyme Receives Priority Review by FDA for Treatment of Niemann-Pick Disease Type C
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
NICE Reverses Disapproval of AstraZeneca’s Lung Cancer Therapy Tagrisso
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
FDA Approves Edwards’ Sapien 3 for Cardiac Treatment
Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new...
FDA and NMPA Grant BeyondSpring Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication
BeyondSpring, a global biopharmaceutical company focusing on immune-oncology therapy treatments for cancer patients, received today (9/8) breakthrough therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) as well as the China National Medical...
FDA Approves Liquid Biopsy Tests
The U.S. Food and Drug Administration (FDA) has approved the usage of the Guardant360 CDx and FoundationOne Liquid CDx liquid biopsy tests for a number of solid tumors. The biopsies will be conducted via the blood, hence making them less painful, and more accessible....
Clinical Trials During COVID-19: A Glimpse into a Healthier World
While COVID-19 has caused many interruptions across industries, the drug development and supply chain has experienced some of the most severe repercussions. With potential exposure to the virus limiting number of trial participants, as well as site staff and...
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