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The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
The Critical Path Institute has formed the Global Pediatric Clinical Trials Network Pre-Launch Consortium to facilitate treatments for infants, children and adolescents — a top FDA priority. Read More
Bristol-Myers Squibb cut short a Phase 3 study of Opdivo for the treatment of renal cell carcinoma after the immunotherapy drug met its primary endpoint versus everolimus, the current standard treatment. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
Clinical trial sites developing a quality management system must ensure there is a review cycle for documents and procedures so they don’t become stagnant, an expert advises. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More