2018年全球新药研发报告——第2部分：趋势与挑战（Ⅵ）

A Report of New Drugs Research and Development in 2018——Part Ⅱ: Trends and Challenges(Ⅵ)

从制药产业的全局着眼,重点探讨2018年那些最令人瞩目的事件,包括埃博拉疫情在刚果的大规模持续性爆发,基因编辑技术CRISPR的潜在应用及滥用等。与往年一样,报告还将继续回顾孤儿药的开发情况,新的监管支持政策,如欧盟的优先药物制度(PRIME)和日本的Sakigake制度,企业研发管线的损耗,以及值得关注的制药/生物技术公司的兼并与收购。最后,报告还对2019年即将获批的新药进行了预测。

This eagle’s-eye overview of the drug industry in 2018 provides insight into some of last year’s top stories, including a large and still growing outbreak of Ebola in the Democratic Republic of the Congo, as well as the potential uses(and abuses) of CRISPR technology. As in previous years, we also review orphan drug development, new regulatory agencysupported programs such as Priority Medicines Scheme(PRIME) and Sakigake, pipeline attrition, and pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2019.