Endo lifted its stay of litigation against the FDA and is going ahead with a lawsuit challenging the agency’s policy on bulk drug compounding. Source: Drug Industry Daily

Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Source: Drug Industry Daily

The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of…

Merck and GlaxoSmithKline called for more information from the FDA in comments on the agency’s draft guidance for sponsors using the limited population pathway for antibacterial and antifungal drugs (LPAD).…

Purdue Pharma violated a 2015 agreement with New York by deceptively marketing opioids, including Oxycontin, New York Attorney General Barbara Underwood alleges in a new lawsuit. Source: Drug Industry Daily

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Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention.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…