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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
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
Japan on Wednesday launched a new government agency to spearhead medical research and drug development through partnerships with industry and academia. Read More