Oct 23, 2020 | News, Regulatory
With the spike in COVID-19 cases worldwide, there is an increasing amount of people who are seeking precautionary vaccines for respiratory issues in preparation for the winter. Merck’s Pneumovax 23, more specifically, has hit record high sale volumes worldwide in the... 
Oct 21, 2020 | News, Regulatory
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... 
Oct 20, 2020 | News, Regulatory
Today (10/20) AmacaThera was granted approval from Health Canada to send their post-operative long-term anesthetic into phase one of clinical trials. This is the first drug they have sent through the clinical trial phase a milestone for the company. AmacaThera was... 
Oct 19, 2020 | News, Regulatory
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... 
Oct 16, 2020 | Clinical Trials, Health, Innovation, Medical Writing
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... 
Oct 15, 2020 | News, Regulatory
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... 
Oct 14, 2020 | News, Regulatory
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... 
Oct 13, 2020 | News, Regulatory
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... 
Oct 12, 2020 | News, Regulatory
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... 
Oct 9, 2020 | News, Regulatory
Marksans Pharma and Sun Biophamrmaceuticals Industries are facilitating recalls through the FDA of their drug Metaformin as a result of high NDMA (N-nitrosodimethylamine) it contains. The FDA released a comprehensive list of Metaformin products being recalled. It is...
