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.
FDA Grants Novartis Entresto® Expanded Indication for Chronic Heart Failure
The U.S. Food and Drug Administration (FDA) has granted Novartis’ Entresto expanded indication for chronic heart failure, making it the only drug therapy approved in the US to treat patients afflicted with guideline-defined heart failure. Approximately 83% of...
OSE Immunotherapeutics Strengthens IPR for Anti-interleukin-7 Receptor (IL-7R) Antagonist OSE-127/S95011
OSE Immunotherapeutics, a clinical stage biotechnology company, announced today (2/17) that it was granted a patent by the European Patent Office (EPO) for its anti-interleukin-7 receptor (IL-7R) antagonist OSE-127/S95011. The patent, set to last until 2037, covers...
AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO
The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations...
FDA Grants EUA for New Molecular COVID-19 Diagnostic Test
The U.S. Food and Drug Administration (FDA) granted BD Emergency Use Authorization (EUA) for a new molecular diagnostic test for COVID-19 and the Influenza A+B virus that provides results within 2-3 hours. The test has already been CE marked for the IVD Directive....
FDA Issues EUA for Eli Lilly’s Antibody Combination for Mild to Moderate COVID-19
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) the Eli Lilly’s etesevimab in combination with another AbCellera and Eli Lilly’s monoclonal antibody bamlanivimab for treating mild to moderate COVID-19 in patients 12 years or...
Pfizer Withdraws Application for EUA of COVID-19 Vaccine in India
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Amarin Announces Update on Mainland China and Hong Kong Regulatory Review Processes for VASCEPA® (icosapent ethyl)
Amarin Corporation PLC announced today (2/9) that its corporate partner, Edding, has progressed VASCEPA® (icosapent ethyl) for Hong Kong and Mainland China’s regulatory review processes. Based on the clinical data for VASCEPA®, including Phase III studies...
FDA Gives Breakthrough Device Designation for Puzzle Medical Devices Inc.’s Transcatheter Heart Pump
The U.S. Food and Drug Administration (FDA) has granted Puzzle Medical Devices Inc. a Breakthrough Device Designation for its minimally invasive transcatheter heart pump. The revolutionary device is meant for patients with minimal trauma for blood components to...
J&J Submits Single Dose COVID-19 Vaccine to FDA
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
Ensuring Biocompatibility for Medical Devices
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have...
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