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.
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.
Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.