US FDA grants accelerated approval to CSL Behring Factor XIII drug
This article was originally published in Scrip
The US FDA granted accelerated approval to CSL Behring's Corifact as the first therapy in the US to treat congenital Factor XIII deficiency, a rare genetic condition in which patients' bodies are unable to generate enough Factor XIII, the protein responsible for stabilizing the formation of a blood clot. Factor XIII deficiency is the rarest of all factor deficiencies, affecting about one in every five million births. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding in children and adults, with newborns also experiencing umbilical cord bleeding.
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.