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In an effort to stay ahead of the threat of evolving superbugs, the National Institutes of Health announced it will fund novel antibiotic research to either complement or replace existing drugs. Read More
Prizing collaboration and reduced burdens on drugmakers, the European Medicines Agency hopes to bolster a stronger drug development process in the coming years. Read More
The Biotechnology Innovation Organization and a Duchenne patient advocacy group are joining forces to help drugmakers design clinical studies with patient input and drive rare-disease research. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
Following the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More
Drugmakers need to better connect their clinical and R&D operations to cope with the growing cost and complexity of clinical trials amidst declining drug approvals. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of diseases and outcome measures gathered together under a new pilot program. Read More
Robert Califf, President Barack Obama’s choice to head the FDA, is calling for clinical trial reform, but does not believe new regulations are needed. Read More
Titan Pharmaceuticals won positive news from an FDA advisory committee Jan. 12, with panelists voting in favor of approving its implant to treat opioid addictions. Read More
Effective standard operating procedures are central to any life sciences company, but the FDA’s pharmaceutical regulations don’t mention SOPs specifically. Instead, regulations refer to “procedures” related to quality control and require them to be maintained in writing. Read More