- Policy
- ‘Policy support enabled the prompt approval of Envlo’
- by Lee, Hye-Kyung Sep 4, 2024 05:49am
- The backstory of Daewoong Pharmaceutical's Envlo 0.3mg (enavogliflozin), which is a representative success case of the MFDS’s expedited review process, was introduced recently. The government’s policy support for the commercialization of innovative products was what enabled Envlo’s clinical trial to approval in just 5 years. In general
- Policy
- Alvogen voluntarily recalls Comtan Tab due to impurities
- by Lee, Hye-Kyung Sep 3, 2024 05:53am
- Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities. The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities. On March 30, MFDS ann
- Policy
- Prolia’s drug price cut 30% before the entry of biosimilars
- by Lee, Tak-Sun Sep 3, 2024 05:53am
- Prolia, the No. 1 product in the domestic osteoporosis treatment market, has had its upper insurance price limit adjusted this month through price-volume agreement (PVA) negotiations. The drug underwent 4 PVA negotiations in total, which led to a price drop of nearly 30% from the initial price it received in October 2017 upon reimbursement.
- Policy
- Rival party heads discuss pending issue in NA
- by Lee, Jeong-Hwan Sep 3, 2024 05:53am
- Dong-hoon Han, Chairman of the People Power Party, and Jae-Myung Lee, Chairman of the Democratic Party of Korea met at the National Assembly on the afternoon of the 1st and reached a consensus on resolving the parliamentary conflicts and medical gap. Han mentioned the need to resolve the public's anxiety over the medical gap, while Lee sugge
- Policy
- Usage recommendations for 3 JAK inhibitors to be changed
- by Lee, Tak-Sun Sep 3, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) will implement changes to approval for Janus Kinase (JAK) inhibitors, recommending low dosages when used to treat high-risk patients. This is a follow-up measure to the changes to the efficacy and effectiveness section for high-risk patient treatment in 2022. On August 30th, the MFDS posted
- Policy
- Pfizer's new COVID-19 vaccine wins nod in KOR
- by Lee, Hye-Kyung Sep 2, 2024 05:48am
- The new vaccine, JN.1, developed against emerging COVID-19 subvariant, received approval in South Korea. The Ministry of Food and Drug Safety (MFDS) announced on August 30th that it had completed approval just under two and a half months after application was submitted. A designated review team was formed following the plan announced by t
- Policy
- Nicergoline for dementia listed at 50% of the highest-priced
- by Lee, Tak-Sun Sep 2, 2024 05:48am
- Before March this year, there were only two products containing the active ingredient nicergoline available. However, the number quickly increased, resulting in nearly a 50% difference between the highest and lowest prices. The prices of the listed products are getting cheaper with a stepwise pricing system applied. This reflects that more
- Policy
- Lily's orphan drug 'Jaypirca' receives conditional approval
- by Lee, Hye-Kyung Aug 30, 2024 05:50am
- 'Jaypirca,' a designated orphan drug for the treatment of Mantle Cell Lymphoma that recently received marketing authorization in South Korea, is expected to submit the Phase 3 trial results showing therapeutic confirmation by March 2027. As it received conditional approval based on Phase ½ clinical trial results, the company must compare
- Policy
- Reimb standards set for biliary tract cancer drug Pemazyre
- by Lee, Tak-Sun Aug 30, 2024 05:50am
- Pemazyre (pemigatinib), a targeted therapy for biliary tract cancer supplied to Korea by Handok, has successfully received reimbursement standards from the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDDC). The reimbursement standards for the immuno-oncology drug Tevimbra were also set at the meeting. Mer
- Policy
- Prices of Dukarb, Rosuzet cut 3 yrs through PVA
- by Lee, Tak-Sun Aug 30, 2024 05:49am
- The insurance ceiling price of 6 drugs has been cut for 3 consecutive years through the price-volume agreement ‘Type C’ negotiations. According to the industry on the 28th, 6 drugs, including Boryung Pharmaceutical’s 'Dukarb', Dong-A ST 'Growtropin II Inj’, Hanmi Pharmaceutical’s 'Rosuzet Tab', Janssen Korea’s 'Concerta Oros ER Tab’
