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The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
The average cost of developing a new drug continues to rise, even as approval rates decline, according to a report that pegs the cost of ushering a candidate through FDA approval at $2.6 billion. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
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
A federal court panel has resurrected a class action lawsuit against Pfizer that alleges the drug giant deceived shareholders by downplaying cardiovascular risks linked to Celebrex and Bextra. Read More
Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light Friday from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method. Read More