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Biogen and Eisai’s lecanemab — the antiamyloid antibody that recently posted the best-ever Alzheimer’s disease (AD) phase 3 data — shouldn’t cost more than $20,600 per year to be considered a cost-effective therapy for the disease, according to a new draft analysis by the Institute for Clinical and Economic Review (ICER). Read More
In this special report, Drug Industry Daily examines the progress made this year in pursuit of lower drug prices. Part 1 focuses on efforts by lawmakers and the Biden administration.Read More
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The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee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