- Policy
- PVA monitoring for high-priced drugs conducted in Q4
- by Jung, Heung-Jun Sep 25, 2025 06:12am
- High-priced anticancer drugs, including Keytruda and Opdivo, have been placed under monitoring for price-volume agreements (PVA, Type A·B) in the 4th quarter. On the 23rd, the National Health Insurance Service (NHIS) released ‘prior information on the Q4 monitoring list for drugs subject to PVA (Type A·B).’ A total of 111 items wer
- Company
- Twice-yearly 'lenacapavir' for HIV expected to land in KOR
- by Eo, Yun-Ho Sep 25, 2025 06:12am
- 'Lenacapavir,' a HIV prevention drug taken twice a year, is expected to be marketed in Korea. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing the approval of lenacapavir from Gilead Sciences Korea. The drug was designated as an orphan drug in January. Its specific indication is "a com
- Company
- 'Drug pricing reform is overdue in Korea'
- by Son, Hyung Min Sep 25, 2025 06:11am
- Concerns persist that domestic patients still face slow progress in accessing global new drugs. Although the government has introduced system reforms such as expansion of the risk-sharing scheme and pilot projects linking regulatory approval and reimbursement evaluation, experts argue that the current incentive system for innovative drugs
- Company
- Xeomin marks 20 years since launch…'pure toxin'
- by Hwang, byoung woo Sep 25, 2025 06:10am
- Celebrating the 20th anniversary of Xeomin's global launch, Merz Aesthetics is emphasizing the importance of 'pure toxin' for managing botulinum toxin resistance. The company explains that in an era of repeated procedures, a highly purified toxin can inhibit antibody formation and become as a sustainable treatment option. Merz Aesthetics K
- Company
- 'Drug access still stagnant despite improved survival'
- by Son, Hyung Min Sep 25, 2025 06:10am
- While innovative new drugs have raised survival rates for patients with cancer, rare diseases, and other difficult-to-treat conditions and are transforming the treatment paradigms, industry voices argue that domestic patients' access to such drugs remains limited. Both the introduction rate and approval rate of global new drugs fall short of the
- Company
- Celltrion acquires Eli Lilly's U.S. plant for $460M
- by Sep 25, 2025 06:09am
- Celltrion has signed an agreement with Eli Lilly and Company (United States) for the acquisition of a biopharmaceutical manufacturing plant in Branchburg, New Jersey, for approximately $460 million. According to the Financial Supervisory Service, on September 23, Celltrion plans to make a total investment of KRW 700 billion, covering cos
- Company
- Concurrent reimb review likely for Mounjaro and Ozempic
- by Eo, Yun-Ho Sep 24, 2025 06:25am
- Two anti-obesity drugs that have drawn intense attention may soon undergo reimbursement evaluations for their diabetes indications at the same time. With Novo Nordisk Korea’s Ozempic (semaglutide) already scheduled for review at the upcoming October meeting of the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement E
- Policy
- Parties disagree with non-face-to-face medical service bill
- by Lee, Jeong-Hwan Sep 24, 2025 06:25am
- The government's effort to pass a "one-point" bill on non-face-to-face medical services through the National Assembly's Health and Welfare Committee, Judiciary Committee, and plenary session this month has failed. The chief secretary of the Democratic Party of Korea, Lee Su-jin, on behalf of Vice Minister of Health and Welfare Lee Hyung-ho
- Policy
- MFDS to review Tylenol safety following Trump’s remarks
- by Lee, Tak-Sun Sep 24, 2025 06:24am
- The Ministry of Food and Drug Safety (MFDS) announced that it will carefully review safety concerns regarding Tylenol, following remarks made by US President Donald Trump. On the 22nd (local time), President Trump held a press conference at the White House, stating, “Acetaminophen, widely known as Tylenol, may increase the risk of autism
- Company
- LEO Pharma’s topical JAKi Anzupgo approved in KOR
- by Son, Hyung Min Sep 24, 2025 06:24am
- Global dermatology specialized pharmaceutical company LEO Pharma (General Manager Jung-Bum Shin) announced on the 23rd that its chronic hand eczema treatment Anzupgo (delgocitinib) was officially approved by the Ministry of Food and Drug Safety on the 8th. With the approval, adult patients in Korea suffering from moderate-to-severe chroni
