- Policy
- Six strengths of obesity drug Mounjaro Quick Pen approved
- by Lee, Hye-Kyung Sep 8, 2025 06:16am
- Following its launch in Korea, Eli Lilly has expanded the product lineup of its obesity treatment Mounjaro (tirzepatide) by receiving approval for the Mounjaro QuickPen formulation. On September 5, the Ministry of Food and Drug Safety approved 6 QuickPen doses: 2.5 mg/0.6 ml, 5 mg/0.6 ml, 7.5 mg/0.6 ml, 10 mg/0.6 ml, 12.5 mg/0.6 ml, and 1
- Policy
- Savings of KRW 32.6B expected from 2025 'Type-Da' PVA nego
- by Lee, Tak-Sun Sep 5, 2025 06:20am
- The National Health Insurance expenditure is expected to see a savings effect of approximately KRW 32.6 billion due to this year's negotiation for the 'Type-Da' Price-Volume Agreement. This year's negotiated items total 110, comprising 48 active ingredients. The ceiling price of these items has been adjusted as of September 1. Items subjec
- Policy
- Pilot Drug Approval·Review Coordination Committee extended
- by Lee, Hye-Kyung Sep 4, 2025 06:10am
- The pilot operation period for the Pharmaceutical Approval and Review Coordination Committee will be extended by one year. According to the pharmaceutical industry on September 3, the Ministry of Food and Drug Safety (MFDS) decided to extend the pilot period for the Coordination Committee by one year, starting from August 29. The committee ha
- Policy
- MFDS allocates KRW 812.2 billion for next year's budget plan
- by Lee, Hye-Kyung Sep 4, 2025 06:09am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) has announced that its budget for 2026 has been set at a total of KRW 812.2 billion, an increase of KRW 63.3 billion (8.4%) from this year's budget of KRW 748.9 billion. This budget plan was focused on facilitating the smooth execution of the new government's national ta
- Policy
- HIRA "Reimb application of Wegovy has not been filed"
- by Lee, Jeong-Hwan Sep 4, 2025 06:08am
- The Health Insurance Review & Assessment Service (HIRA) announced that it will conduct a fair and swift evaluation if an application for reimbursement is submitted for Novo Nordisk's popular obesity drug, Wegovy (semaglutide). HIRA clarified that since Wegovy's company has not yet applied for reimbursement, HIRA is yet at the stage of de
- Policy
- Luxturna shows signif improvement in 3 out of 6 patients
- by Lee, Tak-Sun Sep 3, 2025 06:09am
- Luxturna (voretigene neparvovec, Novartis), a one-shot gene therapy that costs approximately KRW 300 million, showed clinically significant changes set by reimbursement criteria in only half of the patients. As indicated in the performance evaluation results disclosed last year, the effectiveness was only 50%. The Health Insurance Revie
- Policy
- Bill to mandate generic substitutions gains momentum
- by Lee, Jeong-Hwan Sep 3, 2025 06:09am
- On September 2, the ruling party introduced a bill to mandate generic (ingredient-based) prescriptions for medicines with unstable supply. The bill establishes the legal basis for “shortage drugs” and allows prescribing by ingredient name instead of brand name. The bill holds significance in that it amends the Pharmaceutical Affairs Ac
- Policy
- Kanarb and Faslodex to keep their price until ruling
- by Lee, Tak-Sun Sep 2, 2025 06:11am
- The drug prices for Boryung's hypertension treatment ‘Kanarb’ and AstraZeneca's anticancer drug ‘Faslodex,’ which were determined to be reduced by the MOHW due to the entry of generics, will be maintained at their previous levels for now. The court has decided to suspend the execution of the price reduction until the first-instance ru
- Policy
- "MFDS' data-based drug shortage response"
- by Lee, Jeong-Hwan Sep 2, 2025 06:09am
- The Ministry of Health and Welfare (MOHW) announced that it will address drug shortages by utilizing information from the "Pharmaceutical Production, Supply, and Prescription Data-based Supply Risk Prediction System," which is currently being established by the Ministry of Food and Drug Safety (MFDS). The MOHW has also proposed drug short
- 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
