Under the President’s FY 17 proposed budget request, the FDA would receive $2.743bn in budget authority appropriations – and many are frustrated with the lack of funding.
Drug industry efforts to develop a Zika vaccine are accelerating but it will be at least 18 months until the first candidates are ready for trials according to the WHO.
Kitov Pharma says filing combo therapy for US FDA review will take less than three years and cost less than $12m thanks to 505(b)(2) pathway.
The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
Lonza will make a candidate heart failure gene therapy for Renova Therapeutics under the second biomanufacturing deal it has signed this week.