The Canadian pharmaceutical company Knight Therapeutics has reportedly sold its Neglected Tropical Disease Priority Review Voucher to Gilead Sciences, making it the first time a tropical voucher has ever been sold. Background FDA maintains two types of priority review voucher programs, which allow companies to have their products reviewed by FDA in just six months instead of 10. The first and oldest of the voucher types is intended to facilitate development of products ...

The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on. Background Historically, many companies seeking product approval in the US avoided clinical studies involving children, wary of ethical problems, a lack of incentives and the potential consequences if testing uncovered new problems. As a res...

The US Food and Drug Administration (FDA) has announced a four-day meeting to discuss clinical endpoints potentially capable of being used to support future drug development in four therapeutic areas. The 19-24 September workshop, entitled " Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) ," is intended to discuss issues related to endpoints for eosinophilic esophagitis, pediatric and adult inflammatory bowel disease (IBD) and parenteral...

Canadian regulators have approved the world's first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics' Prochymal approval for the treatment of graft-versus-host disease (GVHD). GVHD affects patients who have undergone a bone marrow transplant, and results in the transplanted cells attacking the host's own cells. Osiris' Prochymal uses stem cells extracted from the bone marrow of adults, side-stepping ethical issues inherent in...