Graul A I, Serebrov M, Cruces E, Tracy M, Dulsat C
Thomson Reuters, Barcelona, Spain.
BioWorld, Thomson Reuters, Atlanta, Georgia, USA.
Drugs Today (Barc). 2015 Feb;51(2):125-52. doi: 10.1358/dot.2015.51.2.2294598.
2014 was a year of continued high activity in the pharma and biotech industry, as evidenced in part I of this annual two-part review article published last month in this journal (1). As of December 23, 2014, a total of 55 new chemical and biological entities had reached their first markets worldwide, together with another 29 important new line extensions. Another 19 products were approved for the first time during the year but not yet launched by December 23. Furthermore, during the now-traditional year-end sprint, several regulatory agencies issued last-minute approvals for other compounds that missed the deadline for inclusion in that article, bringing the total of new approvals for the year to a somewhat higher number. In addition to the successful development, registration and launch of new drugs and biologics, there are various other trends and tendencies that serve as indicators of the overall health and status of the industry. These include the pursuit of novel programs designed by regulators to stimulate the development of drugs for diseases that are currently under-treated; the regular and pragmatic culling by companies of their R&D pipelines; and the decision to unify pipelines, portfolios and sales forces through mergers and acquisitions.
2014年是制药和生物技术行业持续保持高活跃度的一年，这在上个月发表于本刊的这篇年度双部分综述文章的第一部分中已有部分体现(1)。截至2014年12月23日，共有55种新化学实体和生物制品在全球首次上市，另有29种重要的新产品线延伸产品。当年还有19种产品首次获批，但截至12月23日尚未推出。此外，在如今传统的年终冲刺阶段，几家监管机构在最后时刻对其他未能赶上该文章收录截止日期的化合物给予了批准，使得当年新批准产品总数有所增加。除了新药和生物制品的成功研发、注册和上市外，还有各种其他趋势和倾向可作为该行业整体健康状况和态势的指标。这些包括监管机构为刺激针对当前治疗不足疾病的药物研发而推出的新型计划；公司对其研发管线进行定期且务实的筛选；以及通过并购来统一管线、产品组合和销售队伍的决策。
