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Biotechnology firm Antigenics is preparing to launch a pivotal trial for its cancer vaccine Oncophage — a move that comes in the wake of preliminary data from a late-stage clinical trial that showed the drug extended the survival of advanced skin cancer patients.
The benefits of disclosing clinical trial results on ClinicalTrials.gov outweigh the risks, but the industry now faces an information glut as drug companies begin to publish all data connected to trials, whether scientific or not, in an effort to avoid liability.
The FDA has delayed its decision on Celgene's oral blood cancer drug Revlimid, pending further review of the firm's risk management plan for the drug, but Celgene hastened to say that the delay is only due to a paperwork backup.
Serono and its development partner CancerVax have halted clinical trials and development of an experimental melanoma drug after an independent review found the drug was likely no more effective than a placebo.
Eli Lilly and Centocor have temporarily suspended enrollment in a late-stage clinical trial of their heart treatment ReoPro after a review of preliminary trial data revealed a potential safety problem with the drug.
Drugmakers can reduce their liability risks and avoid other pitfalls associated with establishing clinical trial databases by using a review team to ensure trial results are complete and free of promotional claims, says a GlaxoSmithKline (GSK) executive.
Eli Lilly and Centocor have temporarily suspended enrollment in a late-stage clinical trial of their heart treatment ReoPro after a review of preliminary trial data revealed a potential safety problem with the drug.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has launched an Internet search portal that provides a centralized location to access clinical trial registries and databases worldwide.
When FDA Associate Commissioner Janet Woodcock advocated researching the potential of pharmacogenetics — the study of genetically determined variations in response to specific pharmaceuticals — more than four years ago, most drug companies responded that such research was “too risky.”
Roche and GlaxoSmithKline (GSK) are raising the stakes in the osteoporosis drug market, announcing Sept. 26 they will launch a clinical trial pitting their new monthly osteoporosis treatment Boniva against Pfizer’s Fosamax, the current market leader.