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The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies and terminate ongoing studies. Read More
The FDA issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency. Read More
The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. Read More
Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease. Read More
After a French Phase 1 clinical trial in January designed by Portuguese drugmaker Bial Laboratories left one patient dead and another six hospitalized, an Agency for Medicines and Health Products Safety-appointed committee determined that an “off-target effect” of the compound is a probable explanation of the tragedy. Read More
Celldex Therapeutics has pulled the plug on a Phase 3 trial of immunotherapy Rintega in patients with EGFRvIII-positive glioblastoma after a mid-trial analysis showed the candidate fared worse than a control group. Read More
The UK’s Medicines and Healthcare products Regulatory Agency GCP Inspectorate conducted 125 GCP inspections between April 1, 2013, and March 31, 2014, yielding only two critical findings and 56 major findings among 22 commercial sponsors, according to the agency’s GCP Inspections Metrics Report. Read More
How can sponsors gather postmarket data on pregnant women? When would sponsors need a pregnancy exposure registry as opposed to another collection method, and how should a pregnancy exposure registry be designed? Those questions were the topic of a recent FDAnews webinar on developing innovative approaches to collecting postmarketing safety data in pregnant women. Read More