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San Francisco-based drugmaker Exelixis is halting research into the use of its thyroid cancer therapy Cometriq for treating prostate cancer after the drug failed a Phase III trial for that indication. Read More
Cancer drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental oncology drug vantictumab within the next few weeks, after the FDA removed a partial clinical hold on its clinical trials. Read More
The Therapeutic Goods Administration is looking to Europe for guidance on drug development, including clinical development of biosimilar drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
GlaxoSmithKline and the National Institutes of Health say they are fast-tracking clinical trials of their experimental Ebola vaccine candidates, and that the drugmaker will make up to roughly 10,000 additional doses of the vaccine so that stocks can be made available immediately if results are positive. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Pharmaceutical companies should boost their efforts to collect and analyze demographic subgroup data in clinical trials, including by ensuring studies have enough women, minorities and elderly patients to be consistent with disease prevalence, the FDA has suggested. Read More
Certain general safety testing requirements may no longer be necessary to help ensure the safety, purity and potency of licensed biological products, the FDA said. Read More
The FDA has downgraded its clinical hold on Tekmira Pharmaceuticals’ TKM-Ebola experimental RNA interference therapeutic, a move that could clear the way for the drug’s potential use in individuals infected with Ebola virus. Read More
Sponsors registering new drugs or updating existing drugs on the Australian Register of Therapeutic Goods will need to conduct biopharmaceutic studies and generate specific data on test results, the Therapeutic Goods Administration says. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More