FDA Issues Complete Response Letter for AstraZeneca COPD Drug Application
October 1st 2019AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.
New Virtual Reality Platform Offers Life Sciences Industry Training
September 27th 2019A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.
Pii to Manufacture FDA-Approved Breast Cancer Drug
September 23rd 2019Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.