Russia Approves Trial for COVID-19 Vaccine
Russia’s Health Ministry approved the usage of the “Sputnik” COVID-19 trial vaccine on 110 60+ year-olds today (10/13) in the wake of the deadly virus. Alongside this test will be a larger scale test being carried out in Moscow on 40,000 volunteers as part of a third...
FDA Advisory Committee Passes Alkermes’ Schizophrenia Drug
The U.S. Food and Drug Administration (FDA) Advisory Committee voted 16-1 in favor of passing Alkermes’ schizophrenia and bipolar disorder treatment drug (AKMS 3831). FDA members voiced concern about the potentially addictive qualities of the drug, as it contains an...
NDMA Detected in Dangerous Amounts in Metformin by FDA
Marksans Pharma and Sun Biopharmaceuticals Industries are facilitating recalls through the FDA of their drug Metformin as a result of high NDMA (N-nitrosodimethylamine) it contains. The FDA released a comprehensive list of Metformin products being recalled. It is...
Chinese COVID-19 Trial Approaching End
A United Arab Emirates company, Group42 or G42, is nearing the end of phase 3 clinical trials for a Chinese COVID-19 vaccine. They are hoping to start producing in the masses next year. This potential vaccine was a product of the partnership between G42, an Abu-Dhabi...
COVID-19 Testing System Disrupted Resulting from Roche’s Supply Chain Glitch
Roche, a Swiss pharmaceutical company, was hit today (10/7) with a glitch that disrupted one of its warehouses. This interruption caused one of their main receivers, Britain’s National Health Service, to delay the reporting of nearly 16,000 positive COVID-19 tests....
COVID-19 Antibody Treatment Expansion Following Safety Clearance
GlaxoSmithKline (GSK) and Vir Biotechnology are partnering to conduct trials on an antibody for COVID-19 treatment. The clinical trial will include 1,300 patients globally and a control group receiving a placebo. Various other companies, Regeneron for instance, have...
ABOUT US
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