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Regulatory & Safety: Top Headlines

WHO: Zika vaccine still at least 18 months from clinical trials

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

Telephus gets patents for superbug battling antibodies

12-Feb-2016 - Australia has granted Telephus Medical a patent for an antibody that targets superbugs, including MRSA.

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

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. 

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

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.”

President's US FDA budget a 'barren request'

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.

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

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.

AstraZeneca: China formulated anaemia drug on fast-track, but timeframes vague

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.

Janssen averse to extrapolation as FDA sits to review Remicade biosimilar

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.

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