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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
The European Medicines Agency is revising the way drugmakers conduct studies of drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The FDA is advising devicemakers that plan to support a premarket submission with data from clinical studies conducted outside the U.S. to meet with the agency before finalizing their trial designs. Read More