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Future models for obtaining informed consent from a patient in secondary data-based studies need to consider what patients really care about, a recent study in PLOS One concludes. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for 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 issued final guidance on clinical trial design for drugmakers developing targeted products to treat lupus — in an effort to encourage more companies to target the underserved disease. Read More
The FDA has laid out the procedures drugmakers should follow in preparing for critical path innovation meetings designed to bring drugmakers, patient groups and regulators together to decide how to use experimental and untested methodologies that can advance drug development. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued last month. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued in early March by the Central Drugs Standard Control Organization. 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
A federal judge has ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by Monday, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
Merck’s investigational hepatitis C grazoprevir/elbasvir combination pill has picked up two new breakthrough designations, just three months after the FDA threatened to rescind one it had already granted to the drugs. Read More
The Federal Circuit affirmed most of a 2013 U.S. district court ruling that ordered Apotex to pay AstraZeneca slightly more than $76 million for infringing on patents for its heartburn drug Prilosec. 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