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Two years after the EU implemented landmark pharmacovigilance legislation, European regulators are offering manufacturers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
The U.S. House passed a bill this week that aims to prevent prescription drug abuse and diversion, while ensuring patient access to needed medications, by fostering greater collaboration between drug manufacturers, distributors and regulators. Read More
The European Commission has approved an expanded indication for the blood thinner Eliquis to treat deep vein thrombosis and pulmonary embolism and to prevent recurrent DVT and PE in adults, Bristol-Myers Squibb and Pfizer said Tuesday. Read More
Indian pharmaceutical authorities have enacted price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders, a decision that one industry observer warns will also have a chilling effect on the introduction of patented drugs into the country as branded companies worry that price controls may soon come to their sector as well. Read More
Canadian trade officials are pushing back against Eli Lilly’s $500 million damages claim against the government in an international trade dispute, claiming the brand manufacturer demonstrates a fundamental lack of understanding for Canada’s patent laws and treaty obligations. Read More
Brand manufacturers who use risk evaluation and mitigation strategies (REMS) to delay generic competition by denying product samples to would-be ANDA filers are costing pharmaceutical payers billions of dollars each year, according to a new study commissioned by GPhA. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. 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