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.
Pfizer COVID-19 Vaccine Received Full FDA Approval
Marketed under the name, Comirnaty, The US FDA (Food and Drug Administration) granted the Pfizer-BioNTech COVID-19 vaccine full approval yesterday, the first COVID-19 vaccine to become fully licensed in the US. In the US, the vaccine is now approved for people aged 16...
COVID-19 Shots in Pregnant Women Lead to Antibody Transfer
A study has found that pregnant women who receive their first messenger RNA–based COVID-19 vaccine during their pregnancy, produce antibodies for COVID-19 as early as five days following inoculation. The study also found that within 16 days following the first...
AstraZeneca Therapy Shows Strong Prevention Against COVID-19
British drug maker, AstraZeneca, announced their late-stage clinical trial data shows their new antibody treatment, AZD7442, reduces the risk of developing COVID-19 symptoms by 77%. The study gives hope to sufferers whose immune system did not generate a strong...
Rentschler Begins Commercial Production of CureVac Covid-19 Shot
Rentschler Biopharma is in the final stages of preparations to begin commercial production of CureVac’s COVID-19 Shot. The German contract drug manufacturer built a production site for CureVac’s Vaccine and intends to deliver at least 100 million doses per year....
Brain Cancer – Researchers Testing Drugs Using 3D Printing
Researchers from the Tel Aviv University are testing the efficacy of potential treatments by using patients’ own brain cancer cells to make a 3D model of their tumors. The process includes the extraction of the tumor from a patient diagnosed with glioblastoma, one of...
FDA Approves Abbott’s Amplatzer Amulet Fibrillation
The US FDA (Food and Drug Administration) has approved Abbott’s Amplatzer Amulet left atrial appendage occlude for the treatment of nonvalvular atrial fibrillation in people with a higher risk of stroke and systemic embolism. Abbott's Amulet is characterized by its...
Rocket to Resume Clinical Trial following FDA Hold Lift
The US FDA (Food and Drug Administration) has lifted their clinical hold on Rocket Pharmaceuticals for their experimental gene therapy program for the treatment of Danon disease. Following the decision, Rocket announced it will resume patient enrollment later this...
CytoDyn HIV Justification Report: Guidance From FDA
The U.S FDA (Food and Drug Administration) has provided CytoDyn with guidance on its recent HIV BLA dose justification report, a crucial part of the company’s resubmission for its Biologics License Application (BLA) for HIV. CytoDyn is known for specializing in...
LATAM Series: Venezuela’s Medical Device Regulatory Pathway
Venezuela is the third largest medical device market in Latin America, following Brazil and Mexico, which makes understanding Venezuela’s medical device regulatory pathway crucial for MedTech companies expanding into Latin America (LATAM). Somewhat similar...
FDA Clearance: Syntr Health Technologies SyntrFuge System
Syntr Health Technologies has been granted clearance from the US FDA (Food and Drug Administration) for their SyntrFuge System for surgical use when transferring a patient’s adipose (fat) tissue. Syntr Health Technologies, a medical device company that focuses on the...
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