Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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Moderna Notes Early Signs of Success in Covid Vaccine

Moderna Notes Early Signs of Success in Covid Vaccine

Today (5/18) Moderna announced that its Covid vaccine  clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...

Moderna Moves into Phase 2 of Covid Vaccine

Moderna Moves into Phase 2 of Covid Vaccine

In their business update, Moderna announced they received FDA clearance to move into Phase 2 of their study for the COVID-19 vaccine. In their press release, they also reported additional funding from Biomedical Advanced Research and Development Authority (BARDA) as...

Exploring the World of Vaccinations

Exploring the World of Vaccinations

Explore the world of vaccinations with Professor K in understanding what they are, how they work, and the challenges they face in development and implementation, especially for COVID-19.

FDA Amends Policy for Covid Tests

FDA Amends Policy for Covid Tests

The FDA announced that it would strengthen its oversight for companies marketing the Covid serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...

FDA Grants EUA for Covid Treatment Remdesivir from Gilead

FDA Grants EUA for Covid Treatment Remdesivir from Gilead

The FDA announced today (5/1) that it would grant EUA for Gilead for their antiviral drug remdesivir for treatment in early response to suspected or confirmed patients with Covid. This authorization will allow the distribution of the drug all over the US, as well as...

EU Gives Five New Guidances for Medical Devices

EU Gives Five New Guidances for Medical Devices

The European Commission's Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...

EU Unanimously Votes to Delay EU MDR by 1 Year

EU Unanimously Votes to Delay EU MDR by 1 Year

In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...

Covid, Ebola, and Typhoid,  Oh My!: A Tale of Global Pandemics

Covid, Ebola, and Typhoid, Oh My!: A Tale of Global Pandemics

This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current Covid self-quarantine has brought...

The Effects of Cabin Fever

The Effects of Cabin Fever

Staying at home for extended periods of time, also known as "cabin fever", can feel like entrapment. Especially true for those accustomed to a hyper-connected lifestyle, quarantining can be detrimental to one’s well-being. Not being able to attend a dance class in...

FDA Authorizes First At-Home Covid Testing Kits

FDA Authorizes First At-Home Covid Testing Kits

Yesterday (4/21) the FDA announced EUA for at-home Covid testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...