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The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said in comments on the June 1 draft. Read More
Sen. Orrin Hatch (R-Utah) and Rep. Greg Walden (R-Ore.) urged the Office of Management and Budget (OMB) to consider the potential fallout from the White House’s proposed rule that would remove drugmakers’ anti-kickback protections for prescription drug rebates. Read More
The U.S. District Court for the Eastern District of Pennsylvania denied Johnson & Johnson’s motion to dismiss Pfizer’s antitrust litigation, which alleges that J&J engaged in anticompetitive practices for its biologic Remicade (infliximab) to block biosimilars. Read More
The U.S. delegation to the Sept. 26 United Nations meeting “should include high-level federal officials, representatives from cities and states with high TB burdens, TB programmers, health care providers, representatives from civil society, and Americans affected by TB,” the letter says. Read More
Initially filed in 2013 and most recently amended in December 2016, the complaint claimed the companies falsely marketed Suboxone film as being less vulnerable to diversion and safer than Suboxone tablets. Read More
A bipartisan group of lawmakers urged the White House to push for action to prevent, treat and ultimately eradicate tuberculosis at an upcoming United Nations meeting. Read More
The Justice Department filed notice that it plans to intervene in four False Claims Act lawsuits accusing Indivior and Reckitt of improperly marketing the opioid anti-addiction drug Suboxone. Read More
Taking aim at illicit synthetic opioid distribution, the Department of Justice is launching a Florida operation to prosecute every case of illegal distribution. Read More
Some pharmacies “billed extremely high amounts” for at least one of five measures that OIG has developed as indicators of possible fraud, waste or abuse. Read More