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The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies. Read More
Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More
The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients (API) and finished generic products paying more. Read More
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