Rx Drugs

FDA approved Wednesday (Oct. 18) Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma.

The American Civil Liberties Union (ACLU) Foundation and ACLU of Hawaii Foundation, representing a medical professional and other health organizations, have sued HHS and FDA for what the plaintiffs say are inappropriate and unnecessary Risk Evaluation and Mitigation Strategies (REMS) restrictions on Danco Laboratories' Mifeprex -- also known as the “abortion pill” -- that limit patient access.

Watchdog group Democracy Forward sued the White House Office of Management and Budget for information on the role OMB Associate Director of Health Programs Joseph Grogan played in the delays of the Obama administration's 340B drug ceiling price and manufacturer penalty rule.

President Donald Trump on Monday (Oct. 16) renewed his promise to rein in the cost of prescription drugs.

FDA Commissioner Scott Gottlieb announced Wednesday (Oct. 11) that the agency will establish a patient affairs team that will “be responsible for the coordination of certain agency-wide and multi-center projects related to patient engagement.”

An FDA expert panel unanimously voted Thursday (Oct. 12) to recommend approval of Spark Therapeutics' Luxturna (voretigene neparvovec) -- a gene therapy used to treat patients with a rare form of genetically-inherited blindness -- that some analysts say could cost nearly $1 million per patient.

A federal circuit judge has reversed a lower court's recent controversial decision to order a biologic cholesterol medication to be taken off the market in response to a patent challenge.

House Energy & Commerce Democrats on Wednesday (Oct. 11) touted 340B providers and the programs run off of savings received through that drug discount program, but committee Chair Greg Walden (R-OR) said he was worried about the lack of transparency and dearth of data on how the providers use the program.

FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.