View Post

In the Age of Individualized Medicine, the U.S. FDA Provides Clarity

In COVID-19, Latest News by Precision Vaccinations

“Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases,’ said Patrizia Cavazzoni M.D., Acting Director of the U.S. FDA’s Center for Drug Evaluation and Research.
“In fact, in the past eight years, the FDA has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.”
Excerpts from Dr. Cavazzoni’s press statement on January 4, 2021, are inserted below.

View Post

Rapid Breath Test Detecting COVID-19 Infection Launches Clinical Trial

In COVID-19, Latest News by Precision Vaccinations

Israel based Scentech-Medical announced it had received approval from the Shamir Medical Center Review Board for a new clinical trial to demonstrate its ability to monitor the antibody levels and type of antibodies developed by the population of subjects getting vaccinated for the SARS-CoV-2 coronavirus.
Scentech, which is merging with NextGen Biomed Ltd, reports that using the test developed for the analysis and quantification of volatile compounds in breath can detect coronavirus patients, active, symptomatic, and asymptomatic carriers.

View Post

Moderna Strives to Produce 1 Billion Vaccine Doses

In COVID-19, Latest News by Precision Vaccinations

Moderna, Inc. published a supply update for the experimental Moderna COVID-19 Vaccine, stating the company is increasing its base-case global production estimate from 500 to 600 million vaccine doses for 2021. 
Furthermore, Moderna’s press statement added, ‘it is continuing to invest and add staff to build up to potentially 1 billion vaccine doses for 2021.’
The Company said it expects about 100 million doses to be available in the USA by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.