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The FDA issued a warning letter to active pharmaceutical ingredient (API) maker Nortec Quimica of Brazil for inadequate controls over computer systems and failure to review batch production and laboratory control records prior to API distribution to the U.S. Read More
Astellas Pharma, Pfizer’s Medivation subsidiary and Regents of the University of California have filed a lawsuit alleging that Sun Pharmaceutical infringed on a patent for their blockbuster prostate cancer drug Xtandi (enzalutamide). Read More
The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More
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