The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.

Scrip takes a look at the current landscape in the South Korean digital therapeutics sector, where some remaining gaps in regulation and reimbursement are seen but multiple products are now progressing through pivotal local clinical trials.

Aside from what was generally a strong quarter for South Korean biopharma firms, Hanmi faces mixed news for its US pipeline, Daewoong’s Fexuclue and Nabota expand their market presence, Boryung builds its oncology business and SK Bioscience unveils an updated growth strategy.

At a recent conference in Seoul, senior executives shared views on a broad array of topics around developing globally successful new drugs in an extremely competitive environment, including what could be considered as success. Awareness of patient needs and social value emerged as some key threads.