FDA OK's Unituxin; United Therapeutics wins pediatric voucher
This article was originally published in Scrip
United Therapeutics won FDA approval on 10 March of Unituxin (dinutuximab), a disialoganglioside, GD2-binding chimeric monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid to treat pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Shares of Silver Spring, Maryland-based United Therapeutics rose 2.7% on 10 March, before closing at $163.84, up $3.40, or 2.12%. The FDA also issued the company a rare pediatric disease priority review voucher, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. It is only the second time the US agency has awarded the voucher, which is designed to encourage development of new therapies aimed at preventing and treatment certain rare pediatric diseases. BioMarin won the first-ever rare pediatric disease voucher in February 2014, which it sold this past July for $67.5m to Regeneron and Sanofi.
You may also be interested in...
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.