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.
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...
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...
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