- Company
- Balversa may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Jan 6, 2025 05:56am
- The new bladder cancer drug Balversa may now be prescribed in Korea’s Big 5 tertiary hospitals in Korea. According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul Na
- Policy
- MFDS’s 2nd GIFT drug Nefecon applies for reimbursement
- by Lee, Tak-Sun Jan 6, 2025 05:56am
- Nefecon (micronized budesonide), the only drug approved by the U.S. FDA to treat lgA (immunoglobulin A) nephropathy, has applied for domestic health insurance reimbursement coverage in Korea. The drug was approved in November last year as its 2nd GIFT (Global Innovative Drug Fast Track) drug, MFDS’s fast track program. According to in
- Company
- Lily's 'Jaypirca' launches in KOR
- by Whang, byung-woo Jan 3, 2025 06:28am
- Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26. To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind. Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) i
- Company
- Will Fabhalta settle as a PNH treatment option in Korea?
- by Eo, Yun-Ho Jan 3, 2025 06:27am
- Whether another PNH treatment option will be born is gaining attention in Korea. According to industry sources, Novartis Korea has submitted a reimbursement application for its oral paroxysmal nocturnal hemoglobinuria (PNH) treatment Fabhalta (iptacopan). PNH is a rare disease with an estimated incidence of 1.5 per million people world
- Policy
- 'Pivlaz Inj' makes another attempt to be reimb in KOR
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- 'Pivlaz Inj,' which is supplied·distributed in South Korea by Handok, has been submitted for another attempt at reimbursement. The marketing authorization for Pivlaz was approved in South Korea in December 2023. Then, the company applied for reimbursement but voluntarily withdrew the reimbursement application in June 2024. According t
- Policy
- New Year's drug pricing policy highlights
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- The new drug pricing system in 2025 is expected to be volatile due to Korea’s political turmoil. Whether the external reference pricing reevaluations and re-evaluation of the listed PE exemption drugs, which were reviewed or discussed last year, will be carried out this year is also the focus of attention. However, as most of the detai
- Policy
- Prices for Vyndamax, Ocrevus in negotiations with NHIS
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- Pfizer's cardiomyopathy drug Vyndamax Cap and Roche's multiple sclerosis drug Ocrevus Inj are undergoing drug price negotiations with the National Health Insurance Service (NHIS) in Korea. Therefore, it will be interesting to see if the drugs will be able to finalize negotiations and their reimbursement listing agenda be submitted to the He
- Policy
- Orphan drug 'Voxzogo' wins nod
- by Lee, Hye-Kyung Jan 2, 2025 06:11am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on December 31 that it has approved 'Voxzogo (vosritid),' an orphan drug used to treat achondroplasia in children over four months whose growth plates are not closed. Achondroplasia is a bone growth-related genetic disease caused by a mutation in the FGFR3, a ge
- Policy
- Changes made to the drug approval system in the new year
- by Lee, Hye-Kyung Jan 2, 2025 06:11am
- Various changes will be made to the drug approval and management system in the new year of 2025, including the new drug approval innovation plan. On December 31st, the Ministry of Food and Drug Safety (MFDS) announced the changes that will be enforced from January, including ▲ the implementation of a new drug approval innovation plan ▲ refo
- Company
- Yuhan’s anticancer drug Leclaza secures European approval
- by Cha, Jihyun Jan 2, 2025 06:10am
- Yuhan Corp’s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European
