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 Approves Targeted Treatment for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved Amondys 45 (casimersen) injection from Sarepta Therapeutics for the treatment of Duchenne muscular dystrophy (DMD) in patients that have a mutation amenable to skipping exon 45. DMD is a genetic disorder that causes...
FDA Partially Rescinds Two Supplemental Biologics License Applications
The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the...
Sinopharm Unit and CanSinoBio apply for Public Use Approval of COVID-19 Vaccine in China
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve...
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...
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