ChosunBiz

1 week ago | biz.chosun.com | Yeom Hyun-a

The Ministry of Food and Drug Safety announced on the 30th that it has approved the progressive small cell lung cancer treatment 'IMDELLTRA (IMDELLTRA®; ingredient name talatomab)' by the American company Amgen. Lung cancer is classified as small cell lung cancer when the cancer cells are small and non-small cell lung cancer when they are larger.

1 week ago | biz.chosun.com | Yeom Hyun-a

Major presidential candidates have announced policy promises to actively foster the pharmaceutical and biotechnology industries as new future growth engines. Emphasis was placed on strengthening support for new drug research and development (R&D) to become a leading country in biotechnology. However, there were clear differences in how to implement these policies and approach regulations.

1 week ago | biz.chosun.com | Yeom Hyun-a

Samsung Bioepis announced on the 30th that it has received marketing authorization for the osteoporosis treatment 'Xgeva (active ingredient denosumab)' biosimilar 'Xbryk®' from the Ministry of Food and Drug Safety. Xgeva is an osteoporosis treatment developed by Amgen in the United States, used alongside the endocrine therapy 'Prolia' for postmenopausal osteoporosis and for preventing skeletal complications in patients with bone metastasis as well as in treating giant cell tumors.

1 week ago | biz.chosun.com | Yeom Hyun-a

As policy uncertainty in the United States, the world's largest pharmaceutical market, continues alongside the staffing cuts at the Food and Drug Administration (FDA), concerns over delays in the approval process are rising, leading to increased technology transactions. Global major pharmaceutical companies (big pharma) are securing technology by either introducing late-stage clinical trial candidates or acquiring entire corporations.

1 week ago | biz.chosun.com | Yeom Hyun-a

GemVax announced on the 29th that its progressive supranuclear palsy (PSP) treatment drug 'GV1001' has been designated as an orphan medicinal product (OMP) by the European Medicines Agency (EMA). Earlier this month, it received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA).