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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
Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study. 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
The guideline specifies not only that covariates should be included in the primary analysis but also that sponsors should justify which ones they include. 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
Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. Read More
For the first time, the European Medicines Agency has produced a guideline on clinical trial design for drugmakers developing targeted products to treat lupus — an effort by the EMA to encourage more companies to target the underserved disease. Read More