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The Saudi Food and Drug Authority has set strict new requirements for the import, clearance and export of commercial and investigational drugs, including provisions on drugs for compassionate use and drugs meant for use in clinical trials. Read More
Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
European generics makers are calling on the European Commission to boost job creation and economic growth in Europe by stimulating early export of generics and biosimilars to countries where no patent or supplementary protection certificates exist. Read More
The FDA is inviting web developers to tap into publicly available data on adverse drug events, recalls and labeling and assess their impact for drug research. 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
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
Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More