Government
The settlement stems from multi-year criminal and civil investigations into Purdue’s marketing practices related to its powerful prescription painkiller, OxyContin, which critics have argued facilitated the opioid epidemic.
The U.S. arm of the trial has been paused for more than a month while the U.S. Food and Drug Administration investigates a serious illness that occurred in a patient who received the experimental treatment.
In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease.
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.
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