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.Acute Viral Pneumonia Treatment LungFit Approved by Beyond Air to Enter Clinical Study
In November 2020, the clinical study for treatment of acute viral pneumonia, facilitated by Beyond Air, a medical device and pharmaceutical company, is scheduled to commence. The study will consider enrollment for anyone infected with COVID-19 and pneumonia caused by...
Non-Opioid Pain Management Treatment in Phase One of Clinical Trial
Today (10/20) AmacaThera was granted approval from Health Canada to send their post-operative long-term anesthetic into phase one of clinical trial. This is the first drug they have sent through the clinical trial phase a milestone for the company. AmacaThera was...
At-Home COVID-19 Test Approved by FDA
Today (10/19), the U.S. Food and Drug Administration (FDA) approved Eurofins U.S Clinical Diagnostics at-home COVID-19 test which provides test result within 24 hours and is minimally invasive. This is the first FDA approved self-administered test in circulation from...
Dealing with Data Challenges Associated with COVID-19 Clinical Trials
COVID-19 has disrupted the clinical trial landscape today. The situation has caused many patients not wanting to visit sites, resulting in multiple missed patient visits. The availability of sites and investigators themselves have been limited, since sites have been...
First FDA-Approved Ebola Treatment Produced by Regeneron Pharmaceuticals
Regeneron has yet again added to their arsenal of extremely influential U.S. Food and Drug Administration (FDA) approvals with their Inmazeb antibody, a treatment for children, adults, and newborns with mothers who have tested positive for Ebola, a deadly virus that...
GE Healthcare Introduces Edison HealthLink
Today (10/14), GE announced its new technological innovation to healthcare data collection and safeguarding called Edison HealthLink. It will give clinicians multiple points of access to the Edison ecosystem, enabling them to make fast decisions when needed by...
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...
Categories
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