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“The number of clients whose data is known to have been copied represents approximately one percent of Charles River’s total number of clients,” the company said. Read More
The Department of Justice is offering drug companies on the receiving end of False Claims Act litigation a chance to walk away without crippling fines—as long as they disclose the fraud, cooperate with investigators and fix any underlying problems. Read More
The FDA may start accepting real-world evidence in support of drug applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said Wednesday. Read More
An FDA advisory committee voted Wednesday in favor of Chiesi’s Bronchitol (inhaled mannitol) for improving lung function in cystic fibrosis patients aged 18 and older. Read More
PhRMA on Wednesday pushed back against a final rule that will require drugmakers to offer a treatment’s list price as part of television ads, hinting that a First Amendment lawsuit might be on its way. Read More
Sharpless, who had been serving as director of the National Cancer Institute, acknowledged that it’s a tough act to follow former Commissioner Scott Gottlieb. Read More