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The companies “have inflated the price of insulin and other diabetes-related medication to line their own pockets,” said Arkansas Attorney General Leslie Rutledge. Read More
In the wake of a controversial court ruling affecting orphan drug pricing, Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wisc.) this week introduced legislation that would codify orphan drug exclusivity protections. Read More
A recent FDA warning letter to Brigham and Women’s Hospital cites the Boston, Mass., drug manufacturing facility for lack of aseptic conditions observed during an inspection from August through September 2021. Read More
In the wake of strongly positive data and an FDA go-ahead, Veru will seek an Emergency Use Authorization (EUA) for sabizabulin, its investigational COVID-19 therapy. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is launching a new initiative to speed and increase the development of treatments for rare diseases. Read More
The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More
Human radiolabeled mass balance studies are the most direct way of gathering quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft guidance the FDA issued last week. Read More