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President Trump is being treated with dexamethasone, remdesivir and Regeneron Pharmaceuticals’ investigational antibody cocktail in his battle against COVID-19, following his announcement Friday that he and the first lady had tested positive for the coronavirus. Read More
The FDA issued a warning letter to a drugmaker in India for lacking an adequate environmental monitoring system in its aseptic processing facility. Read More
AbbVie, Abbott Laboratories, Unimed Pharmaceuticals and Besins Healthcare are off the hook for $448 million they would have had to pay to the Federal Trade Commission (FTC), thanks to a favorable ruling by a federal appeals court. Read More
The FDA has hit Mesoblast’s biologics license application (BLA) for Ryoncil (remestemcel-L) with a complete response letter despite a strong vote by the agency’s expert advisory committee vote in favor of the stem cell treatment for pediatric steroid-refractory acute graft vs. host disease. Read More
Gilead Sciences has resumed direct distribution to hospitals of its antiviral drug remdesivir, after HHS decided that the federal government no longer has to control the process because there is a sufficient supply to treat COVID-19 patients. Read More
Pfizer will not allow political arm-twisting to speed up or delay its COVID-19 vaccine candidate trials, the company’s CEO Albert Bourla stressed in an open letter last week. Read More
Pending FDA approval or authorization, the HHS Secretary said Friday he anticipates having enough vaccine manufactured by the end of 2020 to vaccinate certain priority populations and enough to vaccinate all Americans by March to April 2021. Read More
Catalyst Pharmaceuticals saw its lawsuit against the FDA and competitor Jacobus Pharmaceutical dismissed this week by a federal court in Florida. Read More
In recent years, the FDA has tended to approve new opioid drugs “on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug,” according to a new study led by researchers at the Johns Hopkins School of Public Health. Read More