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...
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...
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...
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...
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...
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....
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...
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...
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...
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...
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