- Company
- Long-acting HIV treatment shifts HIV treatment paradigm
- by Whang, byung-woo Jun 18, 2025 05:59am
- With insurance reimbursement now available for the long-acting HIV (human immunodeficiency virus) treatment Vocabria+Rekambys injection therapy, expectations are high on how it will meet the unmet demand. Compared to existing treatments that require daily administration, the new treatment is administered only 6 times a year, offering overwhel
- Policy
- Petition filed urging expedited reimbursement of Livmarli
- by Lee, Jeong-Hwan Jun 17, 2025 06:00am
- A national petition has been filed to urge for the health insurance reimbursement of Livmarli (maralixibat), which is used to treat pruritus (itching) in patients with Alagille syndrome. The petition period runs until the 12th of next month, with over 1,600 signatures signed as of the 16th. Alagille syndrome is a condition in which the in
- Opinion
- [Reporter’s View] Expectations for the second pilot project
- by Eo, Yun-Ho Jun 17, 2025 05:59am
- Several drugs that were undergoing concurrent regulatory approval and reimbursement evaluations for improved patient access are now approaching commercialization. However, whether these drugs will actually receive reimbursement coverage remains uncertain despite expedited approval timelines. Since 2023, the Ministry of Health and Welfare
- Company
- Lotte-Axcelead-Kanaph signs MOU for joint ADC development
- by Kim, Jin-Gu Jun 17, 2025 05:58am
- Lotte Biologics announced on the 16th that it has signed a three-party memorandum of understanding (MOU) with global new drug development company Axcelead and innovative new drug development company Kanaph Therapeutics to establish an ‘ADC Toolbox’ for the development of antibody-drug conjugates (ADC). Under the agreement, the three com
- Opinion
- [Reporter's View] GMP standards for sterile products
- by Lee, Hye-Kyung Jun 17, 2025 05:58am
- The Ministry of Food and Drug Safety (MFDS) is devising measures to reduce the burden on the pharmaceutical industry ahead of the implementation of the 'Revised PIC/S Good Manufacturing Practices (GMP) Guide for Sterile Medicinal Products (guidelines on manufacturing and quality control of medicines)' in December. Following the administrative
- Company
- New RNAi drug 'Rivfloza' gets ODD in KOR
- by Eo, Yun-Ho Jun 16, 2025 06:04am
- The rare genetic disorder treatment 'Rivfloza' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety recently announced this on its notification board. Rivfloza (nedosiran) is indicated to treat children over 9 years of age and above and adults with 'primary hyperoxaluria type 1 (PH1)' and relatively p
- Policy
- Atopic dermatitis drug Ebglyss reimbursed from next month
- by Lee, Tak-Sun Jun 16, 2025 06:03am
- With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis
- Policy
- Roche’s SMA drug Evrysdi Tab approved in Korea
- by Lee, Hye-Kyung Jun 16, 2025 06:03am
- The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ‘Evrysdi 5 mg (risdiplam).’ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet fo
- Company
- Anti-PD-1 immunotherapy 'Zynyz' gets ODD in KOR
- by Eo, Yun-Ho Jun 16, 2025 06:02am
- The checkpoint inhibitor immunotherapy 'Zynyz' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) has recently announced this through its notification board. It is indicated to treat relapsed or metastatic locally advanced Merkel cell carcinoma (MCC). Zynyz (retifanlimab) obtained U.S.
- Company
- Denosumab’s reimbursement denials increase due to stricter
- by Moon, sung-ho Jun 16, 2025 06:02am
- Although the government extended the reimbursed period for denosumab-based osteoporosis treatments last year, concerns about reimbursement denials continue in practice. Major medical societies, such as the Korean Endocrinology Society, have reached the point where they have issued guidelines to prevent insurance reimbursement cuts when prescr
