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.…
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). Source: Drug…
The FDA sent a warning letter to Apotex Research after discovering significant and repeat violations at its Bangalore facility that led to adulterated finished drug products. Source: Drug Industry Daily
Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Source: Drug Industry Daily
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…
An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination. Source: Drug Industry Daily
The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said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…
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…
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…
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections…