- Policy
- Orphan drug 'Jaypirca' for Mantle Cell Lymphoma wins nod
- by Lee, Hye-Kyung Aug 21, 2024 05:47am
- The BTK inhibitor Jaypirca (pirtobrutinib) has been approved in South Korea. The Ministry of Food and Drug Safety (MFDS) announced on August 19th that it approved Jaypirca, an orphan drug for treating Mantle Cell Lymphoma (MCL). Lilly Korea imports the drug. Jaypirca works by binding with Bruton's tyrosine kinase (BTK), which is involv
- Policy
- Reevaluation of foreign drug price comparisons
- by Lee, Tak-Sun Aug 21, 2024 05:47am
- The Health Insurance Review and Assessment Service (HIRA) announced that drug prices will be adjusted in the second half of next year by reevaluating foreign drug price comparisons. This year, an announcement about reevaluation will be made, and the HIRA will conduct the evaluation in the first half of next year. On August 20th, Pre
- Policy
- MFDS reviews COVID-19 drugs Xocova and Lagevrio
- by Lee, Hye-Kyung Aug 21, 2024 05:47am
- Amid the resurgence of the COVID-19 pandemic, The food and drug authorities in Korea have been taking steps to approve COVID-19 treatments. According to the Ministry of Food and Drug Safety (MFDS) on the 19th, the agency began reviewing Ildong Pharmaceutical's ‘Xocova’ and MSD Korea’s ‘Lagevrio,' which the companies have submitted ap
- Company
- Celltrion Pharm announces vision to become ‘Top 5'
- by Kim, Jin-Gu Aug 20, 2024 06:34am
- On the 19th, Celltrion Pharm announced its 'Vision 2030,’ which outlines the company’s vision to become one of the top five pharmaceutical companies in Korea by 2030. Until recently, Celltrion Pharm was promoting a merger with Celltrion, but the plan was reviewed again due to shareholder opposition, upon which the final decision was mad
- Company
- 'Trodelvy' approved for prescription at general hospitals
- by Eo, Yun-Ho Aug 20, 2024 06:34am
- 'Trodelvy,' still not covered by reimbursement, has now been quickly approved for prescription in general hospitals. Sources said that Gilead Science Korea's Trodelvy (sacituzumab govitecan), a treatment for triple-negative breast cancer (TNBC), has cleared drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Med
- Company
- Reimb remains an issue despite broadened options for UC
- by Moon, sung-ho Aug 20, 2024 06:34am
- Urothelial carcinoma, which is a type of bladder cancer, accounts for 90% of all bladder cancers and is considered a typical cancer type in the field. However, unlike other cancers like lung and breast cancer, where the standard of care changes quickly with the introduction of new drugs, UC has remained a barren area for decades, leaving a la
- Company
- K-Pharma focuses on developing CAR-NK cell therapies
- by Son, Hyung-Min Aug 20, 2024 06:34am
- Korean biopharmaceutical industry speeds up the development of chimeric antigen receptor (CAR)-NK cell therapy. GC Cell has recently entered the Phase 1 clinical trial in South Korea. Companies are collaborating on developing CAR-NK therapies through joint-research agreements: GI Cell and Y-Biologics and TS Bio and Maru Therapeutics. NKMAX has c
- Policy
- New criteria set for flexible ICER threshold evaluations
- by Lee, Tak-Sun Aug 20, 2024 06:34am
- The National Health Insurance Review and Assessment Service (HIRA) established new criteria for drugs that apply flexible ICER (incremental cost-effectiveness ratio) thresholds during the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 8th. The previous criteria only stipulated that a flexible ICER threshold
- Policy
- KDCA apologizes for COVID-19 drug shortages
- by Lee, Hye-Kyung Aug 19, 2024 05:47am
- The Korea Disease Control and Prevention Agency (KDCA) apologizes for the COVID-19 medication shortages due to the increased volume of usage than expected. The KDCA stated that after acknowledging the need for medication supply, it had secured medication for 260,000 people after discussing it with the office for national finance. Additio
- Company
- Will Handok’s Empaveli be reimbursed in 1H in KOR?
- by Eo, Yun-Ho Aug 19, 2024 05:47am
- Empaveli, a treatment for paroxysmal nocturnal hemoglobinuria imported by Handok Pharmaceuticals, has entered the final gateway to insurance reimbursement in Korea. According to industry sources, Handok will enter into drug price negotiations with the National Health Insurance Service for its new drug Empaveli (pegcetacoplan). Empaveli is
