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The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
Takeda said Tuesday that the first patient has enrolled in its global Phase 3 study of ixazomib as a maintenance therapy in newly diagnosed multiple myeloma patients. Read More
A federal judge Friday dismissed Teva, Johnson & Johnson, Endo Health Solutions and Actavis from a lawsuit filed by the city of Chicago alleging use of deceptive marketing to sell opioid-based drugs. Two complaints against a fifth company, Purdue Pharma, will proceed. Read More
The National Pharmaceutical Pricing Authority says 59 of the top 100 companies have failed to register with the system, despite several deadline extensions. Read More
Sponsors seeking approval of new drugs based on published literature or postmarketing data must prove that their drug is comparable to its reference product. Read More
The World Health Organization has added new treatments for hepatitis C to its essential medicines list, including Gilead Sciences’ Sovaldi and Harvoni, but says prices must come down before most people will be able to access them. Read More
The European Medicines Agency has granted orphan medicines designation to Hemispherx Biopharma Europe’s experimental Ebola treatment Ampligen. Read More
British drug giant GlaxoSmithKline hopes to cure HIV/AIDS with a first-of-its-kind partnership with researchers from the University of North Carolina at Chapel Hill. Read More
Vertex Pharmaceuticals’ Kalydeco/lumacaftor combination therapy may be in danger as regulators question whether it will provide significant improvements in lung function for most cystic fibrosis patients. Read More