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A federal judge has denied Teva Pharmaceuticals’ motion to dismiss a lawsuit alleging the Israeli drugmaker paid kickbacks to charitable foundations to subsidize Medicare patients’ out-of-pocket payments for its multiple sclerosis drug Copaxone (glatiramer). Read More
A third of the indications for cancer drugs that failed their confirmatory trials after accelerated approval remain on the label for years, with some even getting high endorsements from an alliance of 31 leading oncology centers. Read More
Acting FDA Commissioner Janet Woodcock has sent a letter to the U.S. Patent and Trademark Office (PTO), asking the office to investigate drugmakers’ use of “patent thickets” and other anticompetitive patent practices. Read More
Two outgoing vaccine experts at the FDA as well as experts from the World Health Organization (WHO) are arguing that providing COVID-19 booster shots to the general public isn’t warranted at this time. Read More
Endo International has agreed to pay $50 million to settle lawsuits filed by New York state and two of its biggest counties, Nassau and Suffolk, alleging the Dublin, Ireland, distributer helped fuel the nation’s opioid epidemic. Read More
A Los Angeles doctor is the first individual investigator to receive an FDA warning letter for failing to report trial results to ClinicalTrials.gov, a violation that could result in thousands of dollars in fines, the letter said. Read More
Bausch Health has agreed to pay $300 million in cash to settle an antitrust class action on behalf of consumers over the type 2 diabetes drug Glumetza. Read More
Two moderate Democrats in the House are slated to release a rival Democratic drug pricing bill as the party prepares a sweeping $3.5 trillion spending bill that is expected to include legislation aimed at reducing the cost of prescription drugs, especially for seniors. Read More