(Total Views: 491)
Posted On: 02/04/2021 5:57:16 PM
Post# of 148908
Unbelievable that immunomodulating MABs like leronlimab continue to be ignored. This is really disappointing coming from Dr. Janet Woodcock who I thought would be different. How about supporting a therapeutic that is unaffected by mutations!
Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D.
For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data.
https://content.govdelivery.com/accounts/USFD...ns/2bf92eb
Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D.
For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data.
https://content.govdelivery.com/accounts/USFD...ns/2bf92eb
(0)
(0)Scroll down for more posts ▼
