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.
“Significant Milestones” Reached on Various Regulatory Guidelines Reports ICH
The International Council for Harmonisation (ICH) has reported that "significant milestones" have been reached over the past year. From the adoption of guidances regarding carcinogenicity testing, residual solvent testing, and specifications for electronic Common...
EU Adds Another Blood Condition Side Effect to AstraZeneca’s COVID-19 Vaccine
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca's COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and body...
FDA Grants Pre-Approval for IND for Potential HIV Cure
The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences' Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an...
Delta Variant: Likely More Than 6% of US COVID Cases
Initially detected in India in December last year, the CDC has declared that the Delta variant (B.1.617.2.) can now be found in over 60 countries. The Delta variant appears to have a relatively higher transmissible rate and continues to delay progress combatting the...
EMA Launches Draft for EU Electronic Product Information (ePI)
Following the European Medicines Agency (EMA) and the European Commission and Heads of Medicines Agencies’ (HMA) release of principles outlining a standardized approach to electronic product information (ePI) last year, the EMA is holding a stakeholder consultation to...
Extensive Clinicom Interview: ‘Stigma-Eraser’ and Saving Lives
CSOFT Health Sciences sat down with Dr. Nelson M. Handal, President and Chairman of Clinicom, in our newest podcast episode of Coffee & Conversations to discuss the value of Clinicom’s digital assessment tool in enhancing patient care and eliminating misdiagnoses....
FDA Approves New Pfizer Pneumococcal Vaccine for Adults
A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...
Effective Cardiovascular Results from Lipoprotein Apheresis
A study conducted by the Centre of Nephrology, Apheresis and Dialysis in Germany concluded that Lipoprotein apheresis (LA) is a safe and effective treatment for high-risk dyslipidemia and lowers Cardiovascular rates. The study concluded that LA decreases levels of...
First Alzheimer’s Treatment by Biogen Approved by FDA
The U.S Food and Drug Administration (FDA) has approved Biogen’s aducanumab treatment for Alzheimer's which aims to eliminate the sticky deposits of amyloid beta found in the brains of patients in the initial stages of the disease. In spite of controversy and...
Regeneron COVID-19 Antibody Therapy Approved for Injection
In a move to combat treatment delay, as well as to meet the demand for antibody drugs, the U.S has approved Regeneron Pharmaceutical’s lower dose COVID-19 antibody cocktail that can be administered through injection. The therapy, REGEN-COV, is now permitted to...
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