Breaking News on Global Pharmaceutical Technology & Manufacturing

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President's US FDA budget a 'barren request'

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 saves time and money by filing combo pill through 505(b)(2) pathway

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. 

US FDA halts CTI BioPharma's Ph III cancer drug trial after patient deaths

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 to make heart failure gene therapy for Renova at Houston site

Lonza will make a candidate heart failure gene therapy for Renova Therapeutics under the second biomanufacturing deal it has signed this week.

Recipharm to invest €40m in serialization tech ahead of EU and US track and trace rules

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.

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