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The Institute for Clinical and Evidence Review (ICER) has tackled two disparate pricing regimens, suggesting that Pfizer cut the cost of its COVID-19 antiviral treatment Paxlovid by more than 80 percent and that ublituximab, TG Therapeutics’ potential blockbuster for multiple sclerosis (MS), wouldn’t be worth more than $55,081 per year if approved. Read More
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