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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.
Built with an audacious goal to use AI to unlock the secrets of protein structure and function, Generate Biomedicines believes it is now on the cusp of a drug discovery revolution.
EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.
Experts shared views at a recent conference in Seoul on how the Korean biopharma industry has evolved and what needs to be done to move forward in the next 10 years. Policy efficiency and family ownership in the sector came in for particular scrutiny, with some calling for sweeping changes.
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