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.
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...
Phase 3 Trial of Johnson & Johnson COVID-19 Vaccine Underway in Spain
The Agency for Medicines and Health Products, the Spanish health regulator, has just approved the trial of the second segment of Phase 3 for Johnson & Johnson COVID-19 vaccine in 9 hospitals across the country. The New Brunswick based...
At-Home COVID-19 Test Gets FDA Emergency Use Authorization
Lucira Health, a California based company, has just received emergency use authorization (EUA) status from the U.S. Food and Drug Administration (FDA) for its fully-at-home COVID-19 diagnostic test. It will be available on a national level in Spring of 2021...
Moderna COVID-19 Vaccine Candidate Shows 95% Efficacy Rate
Based on long-term data from a late-stage trial including 30,000 participants, Moderna’s COVID-19 vaccine candidate has shown results of a 95% efficacy rate in fighting the virus. Moderna is planning to file for Emergency Use Authorization (EUA) in the coming...
Novum IQ Infusion Platform Gains Marketing Approval from Health Canada
Baxter Canada is increasing their product line in the realm of medication delivery and management with Novum IQ large volume syringe pumps, as they have just received marketing approval. The medical device uses new infusion protection...
Treatment Resistant Depression
Treatment resistant depression (TRD) describes various forms of depression that have undergone treatment and seen minimal, if any, long-term positive results. With depression affecting 6.7% of the United States’ population and over 300 million people worldwide, the...
Russia Announces Interim Results, Show Sputnik-V is 92% Effective in COVID-19 Protection
As Russian drug-makers surge to keep pace with Western pharma companies in the race for a COVID-19 vaccine, Russia has derived results from a late stage human trial on their own candidate, Sputnik-V. Their sample size of 20 participants was far smaller than...
Emergency Use Authorization Granted to Ab-Cellera Antibody
Bamlanivimab, an antibody effective in treating mild to moderate COVID-19 cases in adults and pediatric patients over 12 years of age who are at a high risk of hospitalization, was released today (11/10) by Ab-Cellera. Following their Phase 2 clinical trial,...
Categories
ABOUT US
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