Government
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The grant was awarded by the U.S. Dept. of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
The WHO’s SOLIDARITY clinical trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.
Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcoholic.
The FDA placed the hold onto the program hold pending the resolution of certain chemistry, manufacturing and controls (CMC) matters, Voyager said.
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