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The FDA issued a warning letter to NuCare Pharmaceuticals in Orange, California for failing to fix drug listing deficiencies in the agency’s database. Read More
Public Citizen has petitioned the FDA to immediately withdraw the approval of AMAG Pharmaceutical’s preterm birth injection Makena (hydroxyprogesterone caproate) because of the failure of a post-market clinical trial. Read More
The Institute for Clinical and Economic Review (ICER) flagged Humira, Rituxan and Lyrica as the top three most costly U.S. drugs in terms of price-hikes in 2017-2018 that were not supported by new clinical evidence. Read More
California’s Governor Gavin Newsom has signed into law the nation’s first legislation barring drugmakers from paying other companies to delay competing generics. Read More
Texas drugmaker Isotherapeutics was hit with a Form 483 for multiple violations at its Angleton facility, including problems with its cleanrooms. Read More
Twenty five state attorneys general pushed back against a request by Purdue Pharma to suspend all litigation against the company and the Sackler family, arguing in two multistate filings that the family can well afford to proceed with the court cases. Read More
In a win for OSI Pharmaceuticals, the U.S. Court of Appeals for the Federal Circuit reversed a ruling by the Patent Trial and Review Board that overturned OSI’s patent for non-small cell lung cancer drug Tarceva (erlotinib). Read More