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.
GBA-Health 2020 Annual Panel Discussion: An Interview with Co-Hosts Sam Olson and Brigid Delaney
In the face of global issues in the life sciences sector, cross-border communication and collaboration are more important than ever. To address this need, CSOFT co-organized the GBA-Health 2020 Panel Discussion on cross border opportunities and challenges in the life...
World Health Organization (WHO) Considers E-Vaccination Certificates
Today (12/3) a World Health Organization (WHO) medical expert divulged the organization’s discussions on an e-vaccination certificate for recovered COVID-19 travelers. The WHO has previously expressed concerns regarding "immunity passports" recommendations,...
Center for Disease Control (CDC) Adjusts Quarantine Guidelines
The U.S. Center for Disease Control (CDC) provided an alternative option to a 14-day quarantine standard, advising that patients with a negative test quarantine for 7 days, and those asymptomatic with no test results for 10. The adjustments were made in hopes to...
Review of Johnson & Johnson’s COVID-19 Vaccine Underway
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and...
Moderna Requests FDA Emergency Use Authorization for mRNA-1273
Today (11/30) Moderna announced their plans to seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine candidate that reported a 94.1% efficacy rate. The study, that evaluated over 30,000 U.S participants,...
The Importance of Cross-border Cooperation at an International Event: A Reflection
In such a turbulent year, cross-border cooperation pertaining to global health has never been more important. Last week, CSOFT supported panel discussions at the Shenzhen 2020 International BioTech and Health Expo, with CSOFT CEO Shunee Yee joining speakers from key...
FDA Breakthrough Device List Includes Breast Cancer Treatment
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
Essential Tremor Treatment Receives Funding from National Health Service (England)
INSIGHTEC, a global healthcare therapeutics company, has received funding from England’s public healthcare provider for their neurological disorder treatment, one that effects 41 million people globally. The treatment utilized acoustic sound energy, a...
WHO Declares Gilead’s COVID-19 Fighting Drug Ineffective
After an expert panel review of Gilead’s Remdesivir, no evidence was found that it was effective in treating COVID-19. In October, the U.S. Food and Drug Administration (FDA) granted the drug approval for usage in hospitals, and after rescinding the...
B-Cell Lymphoma Drug Receives FDA Priority Review
ADC Therapeutic’s Biologics License was approved by the U.S. Food and Drug Administration (FDA) for their relapsed/refractory diffuse large B-cell Lymphoma drug candidate. The antibody conjugate drug, that catalyzes cancer cell death is being investigated in a...
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CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com