- Policy
- Janssen seeks reimb for Balversa in Korea
- by Lee, Tak-Sun Dec 9, 2024 05:46am
- ’Balversa (erdafitinib, Janssen),’ which has been approved as a targeted therapy for bladder cancer, has reportedly applied for reimbursement 2 years after being approved in Korea. It is believed that the company is seeking Balversa’s entry into Korea’s health insurance market based on its proven effectiveness in patients who have used
- Policy
- Reimb extension discussions for Kyprolis break down
- by Lee, Tak-Sun Dec 6, 2024 05:57am
- The proposal to extend reimbursement coverage for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has failed to make it past the negotiating stage with the National Health Insurance Service. The negotiations, which began last October, have broken down. The National Health Insurance Service announced the news of Kyprolis' negoti
- Company
- ‘Various treatment options emerged for ulcerative colitis'
- by Son, Hyung Min Dec 6, 2024 05:57am
- “Various treatment options such as biologics and JAK inhibitors have emerged for ulcerative colitis, but the patients’ options are limited because the government does not allow switching between drugs. Especially as the number of young patients in their 20s and 30s and their life expectancy is both increasing, securing various treatment op
- Policy
- Expanded clinical use of orphan drug 'Joenja' in children
- by Lee, Hye-Kyung Dec 6, 2024 05:56am
- The administration·dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded. The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicat
- Policy
- Linking 'Prior review-performance evaluation-reevaluation'
- by Lee, Tak-Sun Dec 6, 2024 05:56am
- The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs. In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a pre
- Company
- Roche's new PNH drug 'Piasky' expected to be launched in KOR
- by Eo, Yun-Ho Dec 6, 2024 05:56am
- A new PNH drug, 'Piasky,' is expected to be launched in South Korea. According to industry sources, Roche Korea is currently undergoing the approval review process for Piasky (crovalimab), a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). This drug received the U.S. Food and Drug Administration (FDA) approval in June. In Augus
- Company
- GC Biopharma will distribute and sell Fluad Quad in Korea
- by Kim, Jin-Gu Dec 5, 2024 05:53am
- GC Biopharma will distribute and sell CSL Seqirus’s quadrivalent flu vaccine, ‘Fluad Quad Prefilled Syringe (Fluad Quad),’ in Korea. According to industry sources on the 3rd, GC Biopharma recently signed a contract with Meditip to distribute and sell Fluad Quad in Korea. Meditip holds the domestic rights to the main product of the A
- Policy
- Astellas’s Xtandi Tab 40mg and 80mg approved in KOR
- by Lee, Hye-Kyung Dec 5, 2024 05:53am
- Astellas, the original company of the oral androgen receptor inhibitor (ARTA) class prostate cancer treatment, became the first company to receive marketing authorization for the tablet formulation of Xtandi in Korea. The Ministry of Food and Drug Safety approved two dosage forms of Astellas' Xtandi Tab - 40 mg and 80 mg &8211; on Mar
- Opinion
- [Reporter's View] Restricting vs expanding access
- by Eo, Yun-Ho Dec 5, 2024 05:53am
- The addition of a post-listing control system seems to be a fixed deal. The establishment of the Drug Performance Evaluation Office under the Health Insurance Review and Assessment Policy Research Institute has already taken place, and government officials have been publicly discussing using RWD (Real-world data) for drugs subject to the exe
- Company
- Sales of new CAR-T drugs Carvykti 88%↑· Kymriah stalled
- by Son, Hyung Min Dec 5, 2024 05:53am
- Sales performance of Chimeric Antigen Receptor (CAR)-T Cell therapies has been interchanging. Novartis' Kymriah, which entered the market first, is troubling as latecomer competitors enter the market. In contrast, sales of Jansen's Carvykti and BMS' Breyanzi expanded significantly due to expanded indications. According to the pharmaceutical i
