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The FDA said it plans to reach out to drug manufacturers that turn down oncologists’ requests for single patient investigational new drugs (INDs) through a pilot program designed to restructure applications for expanded access. Read More
The House on Thursday passed a seven-bill package by 234-183 votes, including three bills proponents say will reform the drug patent system, speed cheaper generics to market and ultimately lower drug prices. Read More
The Centers for Medicare and Medicaid Services has backed off a proposed rule that would have used the lowest possible payment to a pharmacy as the baseline price for Medicare. Read More
Gilead CEO Daniel O’Day on Thursday defended his company’s handling of its blockbuster HIV prevention pill Truvada before hostile House Democrats. Read More
The acquisition “promises to fundamentally redefine how pharmaceutical and biotechnology companies identify and rapidly enroll patients in precision oncology trials,” Caris said. Read More
“The industry has moved from a fully integrated model, to one which is performed through a ‘virtual’, or fully outsourced approach,” Catapult says. Read More
Pennsylvania’s attorney general filed a new lawsuit on Wednesday against Purdue alleging that the drugmaker sent a torrent of sales representatives to convince doctors in the state to prescribe OxyContin. Read More
A Trump administration directive aimed at keeping the FDA out of the death penalty debate may have pushed the agency right into the thick of it—and may even force drug companies to compel the agency to step in. Read More