- Policy
- Industry requests incentives for rare and orphan drug supply
- by Lee, Hye-Kyung Aug 29, 2025 06:07am
- The pharmaceutical industry has voiced the need for incentives to expand supply support, such as official certification, for companies supplying rare and essential drugs. The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) visited the Korea Orphan & Essential Drug Center on the 28th to review the center's current projects s
- Company
- Ozempic adds indication for patients with diabetes and CKD
- by Son, Hyung Min Aug 29, 2025 06:07am
- Novo Nordisk Korea (General Manager: Kasper Roseeuw Poulsen) announced on the 28th that Ozempic has been approved as a treatment for type 2 diabetes with chronic kidney disease. With this approval, Ozempic is now indicated for: ▲ Use as an adjunct to a two-drug regimen (either alone or in combination with other diabetes medications), in
- Opinion
- [Reporter's View] Innovativeness and trust in healthcare AI
- by Whang, byung-woo Aug 29, 2025 06:07am
- As the innovation of Artificial Intelligence (AI) is robustly developed in the healthcare sector, concerns related to both utilization and implementation are arising. In Korea, the cost required for AI utilization in medical institutions is considered the number one priority for discussion. Additionally, 'awareness' has also been brought
- Policy
- Next year’s reimb reevaluations to be discussed further
- by Lee, Tak-Sun Aug 29, 2025 06:07am
- The government has decided to continue discussions on the 2026 reimbursement adequacy reevaluation plan. While the reevaluation was initially expected to be approved this month through the Health Insurance Policy Deliberation Committee review, it is reported that disagreements remain unresolved regarding selection criteria, procedural i
- Company
- Eylea high-dosage PFS formulation wins nod in Korea
- by Whang, byung-woo Aug 29, 2025 06:04am
- Bayer Korea announced on August 28 that it has received domestic approval for 'Eylea PFS 8mg (aflibercept),' a pre-filled syringe formulation, from the Ministry of Food and Drug Safety (MFDS). The indication for 'Eylea PFS 8mg' has been approved the same as that for the existing Eylea vial formulation. Now, it can be administered more sim
- Company
- "200-day extension for the CMV preemptive therapy Prevymis"
- by Whang, byung-woo Aug 28, 2025 06:10am
- Prevymis (letermovir), a treatment for preventing cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients, is bringing in another paradigm shift as it has entered the '200-day extension criteria.' This drug's influence is expected to grow as the National Health Insurance (NHI) coverage period has been extend
- Company
- Kolon Pharma's active portfolio expansion…new drug·co-dev
- by Son, Hyung Min Aug 28, 2025 06:10am
- Kolon Pharma is increasing its efforts to secure competitiveness in immunology and oncology by combining new drug in-licensing with in-house R&D. Following the introduction of treatments for chronic obstructive pulmonary disease (COPD) and allergies, the company has recently secured a new drug for hypoparathyroidism. Kolon Pharma plans to contin
- Policy
- Bill banning reverse payment agreements passes committee
- by Lee, Jeong-Hwan Aug 28, 2025 06:10am
- The amendment to the National Health Insurance Act, which regulates "reverse payment agreements" where original drug companies and generic drug companies collude by exchanging money to delay or not release generics, thereby avoiding a price reduction for the original drug, passed the National Assembly Health and Welfare Committee review on t
- Opinion
- [Reporter’s View] Addressing the Drug Shortage Issue
- by Kim JiEun Aug 28, 2025 06:09am
- With the bill that revises the Pharmaceutical Affairs Act, centered on simplifying generic substitution notifications, recently passing the NA Health and Welfare Committee's Legislative Subcommittee review, the Korean Medical Association readily voiced its opposition. This amendment primarily expands the scope of post-substitution notific
- Company
- New ADC drug introduced…expands treatment options
- by Son, Hyung Min Aug 28, 2025 06:09am
- New global drugs are awaiting entry into Korea’s antibody-drug conjugate (ADC) market one after another. Following Daiichi Sankyo Korea's application for domestic approval of the ADC anticancer drug ‘Datroway,’ AbbVie Korea is also proceeding with the approval process for its ovarian cancer-targeted ADC ‘Elahere.’ The industry anticipates t
