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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
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design. 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
AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More
Canadian drugmaker Tekmira has halted recruitment of patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More