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NICE is not recommending Enhertu for routine National Health Service use because a clinical trial is ongoing, making the cost-effectiveness estimates very uncertain. Read More
President Biden signed into law a $1.7 trillion omnibus spending package on Dec. 23, appropriating $3.5 billion in discretionary funding for the FDA through Sept. 30, 2023 — an increase of $226 million, or 6.5 percent, from what was enacted for the agency in 2022. Read More
Amgen has become the latest drugmaker to file a lawsuit against HHS over the federal government’s attempts to force pharma companies to provide 340B drug discounts to contract pharmacies. Read More
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The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee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