- Policy
- MFDS approves immune thrombocytopenia drug Tavalisse
- by Lee, Hye-Kyung Jan 23, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS) announced on the 20th that it has approved Tavalisse Tab 100 mg (fostamatinib sodium hydrate), an orphan drug used to treat immune thrombocytopenia in adults. Adult immune thrombocytopenia is an autoimmune disease in which antibodies against platelets are produced and platelets are destroyed in
- Policy
- MOHW to 'carefully review' post-dispensing notification law
- by Lee, Jeong-Hwan Jan 22, 2025 05:54am
- A bill to add the Health Insurance Review and Assessment Service to the post-notification subjects for dispensing substitute drugs by pharmacists is scheduled to be reviewed on the 21st, but the government's cautious stance is expected to be a hurdle. The Ministry of Health and Welfare has not changed its stance on the bill, saying it sh
- Policy
- Yuyu seeks to expand the scope of its fexofenadine to ETC
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Yuyu Pharma, which developed a 60mg OTC drug containing the antihistamine fexofenadine, is now seeking to enter the specialty drug market. Currently, only Handok, the original drugmaker, and Hanmi Pharm own a 180 mg fexofenadine product, but Yuyu Pharma is expected to barge in and pave its way into the two-drug market with its new produc
- Policy
- CKD completes acquisition of diabetes drug 'Januvia'
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Chong Kun Dang has completed the sale transfer and takeover of 'Januvia (sitagliptin phosphate hydrate),' a diabetes drug that generates annual sales of KRW 23 billion in South Korea. Conseqently, what was previously labelled as MSD's is now labelled as Chong Kun Dang's in South Korea. According to industry sources on January 20, the
- Policy
- MFDS approves Vyvgart for severe myasthenia gravis
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced on the 20th that it has approved the orphan drug Vyvgart(efgartigimod alfa) for the treatment of adult patients with general myasthenia gravis (gMG) who are anti-AChR&160;antibody positive. Myasthenia gravis is an autoimmune disease characterized by decreased ne
- Policy
- MFDS' pharma policy keyword, 'shorten time'
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- According to the business plan announced by the Ministry of Food and Drug Safety (MFDS) this year, support policy to facilitate quick market entry for new drugs and innovative products stands out. The 'Ministry of Food and Drug Safety's Major Policy Implementation Plan for 2025' announced on January 21 by the MFDS contains its aim to shorten
- Policy
- Boryung’s Pomalyst generic first to be reimbursed in Korea
- by Lee, Tak-Sun Jan 20, 2025 05:54am
- Boryung will be the first in Korea to receive reimbursement for its generic version of Pomalyst (pomalidomide, BMS), a multiple myeloma treatment. As a product from an innovative pharmaceutical company, the drug also receives premium pricing. According to industry sources on the 17th, four dosage forms (1, 2, 3, and 4 mg) of Boryung's ‘P
- Policy
- Drug expenditures surge due to the use of high-priced drugs
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- Drug expenditures have risen significantly in 2023 due to the rising cost of high-priced anticancer drugs and rare disease treatments. Due to the aging population increasing the expenditures spent on treating chronic diseases, an urgent need has arisen to come up with a measure to reduce drug expenditures. According to the National Health Ins
- Policy
- Pulmonary fibrosis drug 'Ofev' under consideration for reimb
- by Lee, Tak-Sun Jan 17, 2025 05:53am
- As 'Ofev Soft cap (nintedanib),' a treatment for pulmonary fibrosis, has been approved for reimbursement appropriateness, latecomer drugs are projected to enter the market quickly. Following the expiration of Ofev's usage patent, latecomer companies are anticipated to prepare for launching their drugs. According to industry sources on J
- Policy
- Innovative Pharmaceutical Company certification to change
- by Lee, Jeong-Hwan Jan 17, 2025 05:53am
- The Ministry of Health and Welfare will improve the certification system for innovative pharmaceutical companies to a 'certification evaluation score system' that will increase the proportion of new drug research and development (R&D) and change the disqualification criteria to a point-based score system. The MOHW plans to issue an admin
