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The FDA issued a warning about the risk of hepatitis B virus (HBV) becoming an active again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for the hepatitis C virus. Read More
The UK’s price watchdog is recommending the reimbursement of AstraZeneca’s Tagrisso as a second-line treatment for an aggressive form of lung cancer. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
Sen. Charles Grassley (R-Iowa) is pressing Mylan and the Centers for Medicare and Medicaid Services for answers on the misclassification of the company’s EpiPen as a generic for the agency’s drug rebate program. Read More
The Pancreatic Cancer Action Network is planning an adaptive clinical trial that will use genomic profiling to assign individual patients different treatment options. Read More
The FDA has published 30 new product-specific recommendations on the design of bioequivalence studies for ANDAs, while also revising 30 of its previous recommendations. Read More