Government
“The approval of Adakveo marks a new era in the treatment of sickle cell disease, a genetic condition that places an extraordinary burden of unpredictable pain crises on patients and their families,” said Susanne Schaffert, president of Novartis Oncology.
CRO to serve as the Clinical Research Management Support (CROMS)
It is the first BeiGene-discovered drug to be approved.
Management sciences researchers will help agency understand, improve pharmaceutical quality management
The advisory committee voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation, but typically do.
The letter outlines multiple failures, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils.
The agency found that more than 2.8 million antibiotic-resistant infections occurred in the U.S. each year, killing more than 35,000 people.
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), is a bill before the House that is intended to make prescription drugs more affordable for those in the Medicare program.
In its announcement, Solid Biosciences said a patient in its second cohort who was dosed in October experienced a serious adverse event that was deemed related to the drug.
The approval marks the first approved treatment in the United States for this condition.
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