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Advocacy groups are urging the National Institutes of Health (NIH) to keep a lid on the price of a CAR-T therapy if it decides to give an exclusive license to a group of former venture capital firm members. Read More
A Johnson & Johnson unit has agreed to pay $360 million to settle charges of illegally paying kickbacks to Medicare patients using charity funds, the Justice Department announced Friday. Read More
Lelling said the letters do not represent a determination that recipients violated any laws; they are intended to remind prescribers that they’re prohibited from prescribing medically unnecessary or excessive opioids and, are also barred from prescribing them outside the course of professional practice. Read More
The way in vitro companion diagnostics for cancer drugs are labeled sometimes presents a challenge for oncology care, Commissioner Scott Gottlieb said Thursday in announcing new guidance to tackle the problem. Read More
HHS Thursday pushed back against criticism by conservative groups of its proposed demonstration project to link Medicare Part B drug pricing to those of other countries. Read More
The Federal Trade Commission endorsed FDA draft guidance that aims to deter drugmakers from gaming the citizen petition process to delay generics. Read More