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 Makes Recommendations for COVID-19 Variants
The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...
FDA Clears Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module
The U.S. Food and Drug Administration (FDA) cleared Brainlab’s Loop-X® Mobile Imaging Robot and Cirq®, a robotic surgical system. The clearance paves way for Brainlab to market in the U.S. market for both devices. Cirq robotic alignment module is meant for...
FDA Approves First Ever 3D-Printed Bone Replacement
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...
Translating TMFs for Global Clinical Trials
There is no doubt that clinical trials are vitally important in the drug development process. As an increasing number of clinical trials are conducted overseas, sometimes with multiple ongoing studies at once, having in-depth knowledge...
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...
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