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A federal appellate judge has ordered brand firm Endo and generics manufacturer Mylan to continue negotiating a court-mandated settlement that will allow Mylan to market a generic version of Endo’s migraine drug Frova. Read More
The FDA yesterday approved an expanded indication for Janssen and Pharmacyclics’ blood cancer drug Imbruvica to treat chronic lymphocytic leukemia patients who carry a deletion in chromosome 17, which makes them resistant to standard CLL treatments. Read More
In a significant shift in its electronic submission policy, the FDA will require drugmakers to submit certain drug master files and all advertising and promotional materials electronically by 2016. Read More
Manufacturers of nonprescription drugs sold in Australia have until Dec. 20 to include statements on specific risks in the product labeling, according to the Therapeutic Goods Administration. Read More
The UK’s healthcare costs watchdog is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending that doctors prescribe three new generation anticoagulants rather than commonly used warfarin or aspirin. Read More
A loophole in the oversight of active pharmaceutical ingredients and an inconsistent reporting structure are just some of the challenges the U.S. Food and Drug Administration faces in improving drug quality in China, according to the agency’s top official there. Read More
The European Medicines Agency’s Committee for Advanced Therapies has clarified when drugs may be classified as advanced therapy medicinal products, including the criteria for classifying cells and tissues as engineered. Read More
Drugmakers operating in the EU must submit additional information on their authorized products to the European Medicines Agency, starting immediately, and update previously submitted information by year’s end, according to requirements that took effect June 16. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
Sponsors of clinical studies in the European Economic Area ending on or after July 21 of this year must post summary results on the EudraCT clinical trials database by the following July, another step in Europe’s move toward greater trial transparency. Read More