12-Feb-2016 - 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.
News in brief
12-Feb-2016 - Australia has granted Telephus Medical a patent for an antibody that targets superbugs, including MRSA.
11-Feb-2016 - 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.
11-Feb-2016 - 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.”
11-Feb-2016 - 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.
10-Feb-2016 - 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.
09-Feb-2016 - AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.
09-Feb-2016 - Celltrion’s CT-P13 has been declared “highly similar” in safety and efficacy to J&J’s Remicade, and could be recommended for approval by a US FDA committee today.
Regulatory & Safety: Featured news
Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.