COVID-19, Oncology Dominate Korea’s Fast-Track Approval Program
New Breakthrough Therapy Scheme
The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.
You may also be interested in...
South Korea moves to lay out clearer accounting guidelines related to R&D costs for pharma and biotech companies, making improvements to earlier official guidance in 2018 in order to ease uncertainties and help foster the sector.
At a recent forum in Seoul, an executive of Hanmi Pharmaceuticals, whose novel neutropenia drug has just received a US green light, shares why it is crucial to create "blue oceans" through global innovative drug development and how the Korean firm plans to challenge these markets.
Plus deals involving Takeda/Puma, SillaJen/Basilea, Celltrion/Abpro, METiS/Voronoi, Yuhan/AtoGen, Biocytogen/FineImmune and Avance/C3.