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Gilead Sciences subsidiary Kite Pharma has entered into a purchase deal with Tmunity Therapeutics — the company founded by CAR-T cell pioneer Carl June — gaining access to Tmunity’s “armored” CAR-T cell platform. Read More
A federal court has entered a consent decree against Qualgen — an Oklahoma outsourcing facility that has had multiple, previous run-ins with the FDA — prohibiting the compounder from distributing drugs across state lines. Read More
Many of the riders and amendments left on the cutting room floor in September when Congress passed user fee legislation have now been taken up again in a year-end omnibus spending package, a draft of which was released this week. Read More
HHS argues that the program would violate a criminal ban on any remuneration to induce purchase of any item “for which payment may be made in whole or in part under a federal health care program.” Read More
The agency’s expanded approval was supported by results from a study, with 24 percent of participants having had at least one cancerous lesion detected. Read More
The FDA has approved updated labeling for Genentech’s Xeloda (capecitabine) tablets with eight new or revised indications — the first drug to get a labeling update under Project Renewal, a pilot program aimed at updating labeling for older oncology drugs. Read More
Madrigal Pharmaceuticals’ nonalcoholic steatohepatitis (NASH) drug resmetirom has posted strong topline study results showing clinical benefit for patients with liver fibrosis — paving the way for the company to seek accelerated approval early next year. Read More
Alexis Bio and Xeno Therapeutics’ realSKIN, a xenograft cultured from live porcine skin tissue, has become the first non-autologous tissue to win the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation. Read More
Part two of Drug Industry Daily’s special report on the state of Alzheimer’s disease research looks ahead to some promising approaches likely to be developed in 2023 and beyond.Read More