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.
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,...
Pfizer Reaches Breakthrough Results with COVID-19 Vaccine Candidate
Based on initial trial results, Pfizer’s vaccine candidate for COVID-19 has proven to be 90% effective in fighting the virus. Pfizer and their German partner BioNTech expect a regulatory decision for emergency use authorization as soon as...
Brilanta by AstraZeneca Approved to Reduce Risk of Stroke
Brilanta was approved by the U.S. Food and Drug Administration (FDA) for its efficacy in reducing the risk of stroke in patients with acute-ischemic stroke based on the Phase 3 THALES Trial. Compared to aspirin alone, when taken with Brilanta there was a clinically...
Merck Acquires Velosbio for $2.75 Billion for Promising Cancer Therapy
Today (11/5) Merck announced their all-cash acquisition of San Diego’s VelosBio following the release of Phase 1 data of ROR1 targeting VLS-101. VLS-101 is a drug for treatment of hematologic malignancies, and exited clinical trial Phase 1 with results showing...
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