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Ohio will require pharmacy benefit managers (PBM) contracting with its Medicaid program to end their current “spread pricing” arrangements and shift to a more transparent pricing model on Jan. 1. Read More
The U.S. Court of Appeals said AHF could not demonstrate any connection to the intellectual property that gave it standing for a patent case. Read More
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Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention.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The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said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