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The AIDS Healthcare Foundation petitioned the U.S. Supreme Court to review a lawsuit that challenges the validity of Gilead’s patents on its widely-used HIV/AIDS drug Tenofovir Alafenamide (TAF). Read More
Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Read More
The Justice Department launched a new Medicare Fraud Strike Force to target healthcare fraud and illegal opioid prescriptions in Newark, N.J., and Philadelphia — adding to strike forces currently active in 10 other U.S. cities. Read More
PhRMA said it would encourage the FDA “to facilitate a broader conversation among the global regulatory community to promote adoption of similar pragmatic approaches.” Read More
The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each. Read More
The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said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