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A federal court has issued an injunction against cuts to 340B payments introduced last January by the Centers for Medicare and Medicaid Services. Read More
As the federal government shutdown nears the two-week mark, FDA Commissioner Scott Gottlieb continued to issue updates via Twitter in the absence of normal media communications by the agency. Read More
The bureau said it found “insufficient evidence to conclude that the elements of the RevAid program that limit distribution to generics are anti-competitive.” Read More
Democratic legislators, including some possible 2020 presidential contenders, are planning to highlight the hot-button issue of drug pricing in the 116th Congress — although the first order of business will be ending the federal government shutdown. Read More
The motion claims the two attorneys general disclosed details about a forthcoming complaint whose details they did not share with the court or defense. Read More
The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain. Read More
Former Insys CEO Michael Babich has agreed to plead guilty in connection with a kickback scheme involving the company’s Subsys fentanyl spray, the U.S. Attorney for the District of Massachusetts said in a court filing this week. Read More
Some supporters of co-prescribing said labeling could help reach high-risk populations, while others questioned the effectiveness of labeling versus other approaches. Read More